VĂN PHÒNG ĐẠI DIỆN STRYKER SALES CORPORATION ...

Trauma & Extremities Form stnyl<en'TITLE: DECLARATION OF CONFORMITY

VERSION: 4 EFFECTIVE DATE: Date of ECN Release

SYSTEM:

Manufacturer:

VariAx 2 RECORD REVISION: 17

Application of Council Directive MDD 93l42lEEC

Stryker GmbHBohnackerweg 1

2545 SelzachSwitzerland

PhoneFax:

+41 32 641 66 66+41 32 641 66 60

Unique Name of the Medical Device System: VariAx 2

This declaration is issued under the sole responsibility of the manufacturer. l, the undersigned, declare on thebasis of the below information, that the aforementioned system is in compliance with the requirements ofCouncil Directive MDD 93/42|EEC or AIMDD 90/385/EEC or Directive 201413018U or Directive 201413518Uor Directive 20141531ÊU and no further conformity assessment procedures are required.

Except for Class I Medical Devices the Notified Body involved in the Conformity Assessment Procedure is

TÜV SÜD Product Service GmbH lD#0123Ridlerstrasse 65, D-80339 München

Based on the classification criteria described in the Council Directive 93l42lEEC, the products of the abovementioned system have been classified into the undermentioned product classes. Each product classcomplies with Annex I and the applicable Annexes of the aforementioned Directives for its conformityassessment.

The reference number and validity of the EC certificates issued by above Notified Body are listed below

Complies with MDD 93l42lEEC annex Vll

lla Complies with MDD 93l42lEEC annex ll excluding Section 4

Certificate G1 15 05 38979 027 Expiry Date 11.10.2019

ilb Complies with MDD 93l42lEEC annex ll excluding Section 4Certificate G1 15 05 38979 027 Expiry Date 11.10.2019

Form Template DQF 01-006 Revis¡on: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page 1 of 25



SYSTEM: VariAx 2 RECORD REVISION.. 17

This declaration hereby authorizes the CE Mark to be affixed to the below listed products. lt is valid for theproduct lot numbers placed on the markets as of the CE release date. This declaration of conformity is validuntil expiration of the respective EC certificate.

The aforementioned system is in conformity with standards listed in the Essential Requirements (DQF 70-

02A-023/-024/--025/-026) and the Specific Standards List (DQF 10-032).ln particular, electromechanicaldevices are conform to the harmonized standard EN50581, and thereby comply with the European Directive201116518U (RoH52) including Commission Delegated Directive 20151863 (RoHS3) as confirmed in thelisting below. Compliance to RoHS is the sole responsibility of the manufacturer.

This declaration will be kept at the disposal of the competent authorities for a minimum of 30 years after thissystem has been released to the public.

Signed for and on behalf of the above mentioned manufacturer

Name: Marco Zutter Date: 30.08.2017

Title: Senior Manager Regulatory Affairs Place: Selzach

Signature:

Form Templato DQF 01-006 Revision: 1.0 PRINTED COPIËS FOR REFERENCE ONLY Page2 o¡ 25


VERSION 4 EFFECTIVE DATE Ðate of ECN Release

SYSTEM: VariAx 2 RECORD REVISION: 17

REF DescriptionCE release RoHS

2Rule Glass CE Mark Date System

45-35002 VariAx Depth Gauge for 2.713.5mm Screws, Black 6 CE 15.01 .2010 Variax Elbow nla

703663 Screwdriver Blade 18 AO, Self Retaining 6 CE 23.12.2013 VariAx 2 nla

703664 Screwdriver Blade T8 AO b CE 23.12.2013 VariAx 2 nla

703665 Screwdriver Blade T7, AO, self retaining Þ CE 01.03.2011Variax Straight

Platesnla

703667 Screwdriver Blade T10, AO, self retaining 6 CE 01.03.2011Variax Straight

Platesnla

703668 Screwdriver Blade T10 AO 6 CE 23.12.2013 VariAx 2 nla

703669

703671

703675

703684

703686

703687

703688

Screwdriver Blade IB AO, Self Retaining, 60mm

Screwdriver Blade T10 AO, Self Retaining, 60mm

Holding Sleeve Universal

Drill Guide, Comp/Poly Ø2.0mm Drill

Drill Guide 3.5mm indep. lag screw



6 CE 23.12.2013 VariAx 2 nla

6 CE 23.12.2013 VariAx 2 nla

1 CE 23,12.2013 VariAx 2 nla

o CE 23.12.2013 VariAx 2 nla

o CE 23.12.2013 VariAx 2 nla

6 CE 23.12.2013 VariAx2 nla

b I CE 23.12.2013 VariAx2 nla

703690 Drill, AO D2.0mm x 135mm, Scaled o cF.9123 23.12.2013 VariAx 2 nla

703690S Drill, AO D2.0mm x 135mm, Scaled 6 lla cE0r23 23.12.2013 VariAx 2 nla

703691 Drill, AO D2.6mm x 135mm, Scaled b lla cE0123 23.12.2013 VariAx 2 nla

703691 S Drill, AO D2.6mm x 135mm, Scaled 6 lla c80123 23.12.2013 VariAx 2 nla

703694 Overdrill AO, D3.5mm x 122mm 6 Ila cEol23 23.12.2013 VariAx 2 nla

703694S Overdrill AO, D3.5mm x 122mm Þ lla cE0123 23.12.2013 VariAx 2 nla

703695 Overdrill AO, D2.7mm x 122mm 6 lla cE0123 23.12.2013 VariAx 2 nla

7036955 Overdrill AO, D2.7mm x 122mm o lla cE0123 23.12.2013 VariAx 2 nla

703696 Overdrill AO. D2.4mm x 122mm 6 lla cE0123 23.12.2013 VariAx 2 nla

703696S Overdrill AO, D2.5mm x 122mm 6 cEo123 23.12.2013 VariAx 2 nla

703880 Screwdriver Blade, AO, T'10, Self Retaining 6 CE 23.12,2013 VariAx 2 nla

703881 Screwdriver Blade, AO, T10, Self Retaining, 180 mm 6 CE 23.12.2013 VariAx 2 nla

703882

toàBs3

703884

Drill Guide, 2.6mm Drill, Comp/Polyax, T10

Drill Guide, 2.0mm Drill, Comp/Polyax, T10

6 CE 23.12.2013 VariAx 2 nla

6 CE 23.12.2013 VariAx 2 nla

Drill Guide, 2.7mm indep. laq screw 6 CE 23.12.2013 VariAx 2 nla

703885 Depth Gauge,2.4mm - 3.5mm Screws

SpeedGuideTM, for 3.5mm Screws T10 (L = 30mm)

þ CE 23.12.2013 VariAx 2 nla

703886 b CE 23.12.2013 VariAx 2 nla

703887 SpeedGuiderM, for 2.7mm Screws T10 (L = 30mm) 6 CE 23.12.2013 VariAx 2 nla

703888 SpeedGuiderM, for 2.412.7mm Screws TB (L=30mm) b CE 23.12.2013 VariAx 2 nla



703891 SpeedGuiderM Drill, AO, Dia 2.0mm (L = 30mm) 6 lla cE0123 23.12.2013 VariAx 2 nla

703891 S SpeedGuiderM Drill, AO, Dia 2.0mm (L = 30mm) 6 lla cE0123 23.12.2013 VariAx 2 nla

703852

703892S

SpeedGuiderM Drill, AO, Dia 2.0mm (L = 30mm)

ò AO Dia 2.0mm L=

6 lla cE0123 23.12.2013 VariAx2 nla

b lla cE0123 23.12.2013 VariAx2 nla

703893 SpeedGuiderM Drill, AO, Dia 2.0mm (L = 70mm) 6 lla c80123 23.12.2013 VariAx 2

VariAx 2

nla

nla703893S

703894

703894S

703895

703895S

SpeedG TMD AO Dia 2.0mm

SpeedGuiderM Drill, AO, Dia 2.6mm (L = 30mm)

6 c80123 23.12.2013

b lla cE.0123 23.12.2013 VariAx 2 nla

TMD AO Dia 2.6mm = 30mm b cE0123 23.12.2013 VariAx 2 nla

SpeedGuiderM Drill, AO, D¡a 2.6mm (L = 70mm) þ cE0123 23.12.2013 VariAx 2 nla

SpeedGuidcrM Drill, AO, Dia 2.6mm (l = 70mm) 6 lla cE01 23 23.12.2013

23.12.2013

VariAx 2

VariAx 2

nla

703896 Drill Bit, AO, Dia2.Omm x 135mm, Scaled 6 lla cE0123 nla

Form Template DQF 01-006 Revision: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page 3 of 25


2


SYSTEM VariAx 2

Ommx1 m Scaled

RECORD REVISION. 17

703897

6 lla cE0123 23.12.2013 VariAx 2 nla

Overdrill, AO, Dia2.7mm x 122mm b lla c80123 23.12.2013 VariAx 2 nla

703897S Overdrill, AO, Dia2.7mm x 122mm o lla cE01 23 23.12.2013 VariAx 2 nla

703898 Tao. AO. For 3.5mm Screws o lla cE9123 23.12.2013 VariAx 2 n/a

703898S Tao. AO. For 3.5mm Screws o lla cE0123 23,12.2013 VariAx 2 nla

703899 Tap. AO. For 2.7mm Screws 6 lla cE0123 23.12.2013 VariAx 2 nla

703899-S,_

703900

Tao. AO. For 2.7mm Screws 6 lla cEo123 23.12.2013 VariAx 2 nla

Tap, AO, For 2.4mm Screws b lla cE0123 23.12.2013 VariAx 2 nla

703900s703920

Tap, AO, For 2.4mm Screws 6 lla c80123 23.12.2013 VariAx 2 nla

Handle Large 1 CE 29.01.2015 VariAx 2 nla

703521 Handle Medium I CE 29.01.2015 VariAx 2 nla

703922 Handle lnsert, AO, Ratchet, cannulated 1 CE 29.01.2015 VariAx 2 nla

703923

703927

703928

703930

Handle lnsert, AO, cannulated 1 CE 29.01.2015 VariAx 2 nla

Joystick For TB screw holes 1 CE 23.12.2013 VariAx 2 nla

Joystick For T1 0 screw holes 1 CE 23.12.2013 Var'lAx 2 nla

SpeedGuide AO, For 3.5mm Screws, T10 (L = 30mm) 6 CE 30.08.2012 V. Basic lnstr nla

703931 SpeedGuide AO, For 2.7mm Screw, Tl0 (L = 30mm) 6 CE 30.08.2012 V. Basic lnstr nla

703932 SpeedGuide AO, AO, For 2.7 mm TB Screws (L = 30mm) 6 CE 30.08.2012 V. Basic lnstr nla

703933 SpeedGuide Drill AO, Dia 2.0mm (L = 30mm) 6 lla cE0123 30.08.2012 V. Basic lnstr nla

703934 SpeedGuide Drill AO, Dia 2.6mm (L = 30mm) 6 lla cE0123 30.08.2012 V. Basic lnstr nla

703936 SpeedGuide Drill AO, Dia 2.0mm (L = 70mm) 6 cE0123 30.08.2012 V. Basic lnstr nla

703937 SpeedGuide Drill AO, Dia 2.6mm (L = 70mm) lla cE0123 30.08.2012 V. Basic lnstr nla

703938 Bending lron For VariAx Plates 1 CE 23.12.2013 VariAx 2 nla

703939 Bone Holding Forceps with ratchet, L = 168 mm b CE 23.12.2013 VariAx 2 nla

703944 SpeedGuide AO, For 3.5mm T10 Screws (L = 70mm) 6 I CE 30.08.2012 V. Basic lnstr nla

703945 SpeedGuide AO, For 2.7mm T10 Screws (L = 70mm) b I CE 30.08.2012 V. Basic lnstr nla

703948 SpeedGuide Spare Parts Kit (L = 30mm) 6 I CE 30.08.2012 V. Basic lnstr nla

703949 SpeedGuide Spare Parts Kit (L = 70mm) þ I CE 30.08.2012 V. Basic lnstr nla

940081 Frame, 112 Size, 4 Level, Modular Tray 1 I CE 31.03.2014 VariAx 2 nla

940082

940083

Drawer Compression Plate

Drawer T10 3.5/2.7mm Screw

1 I CE 31 .03.2014 VariAx 2 nla

1 I CE 31 .03.2014 VariAx 2 nla

940084 Drawer Reduction lnstrument 1 I CE 31.03.2014 VariAx 2 nla

940085 Screw Rack 110 3.512.7mm 1 I CE 31.03.2014 VariAx 2 nla

940201 Screw Rack Lid 1 I CE 31.03.2014 VariAx 2 nla

940202 Silicone Mat 184 x 104 1 I CE 31 .03.2014 VariAx 2 nla

700664 Hohmann Retractor 6mm Þ I CE 17.08.2005 SPS nla

700665 Hohmann Retractor 8mm 6 I CE 17.08.2005 SPS nla

700667 Hohmann Retractor 15mm b I CE 17.08.2005 SPS nla

702428 T-Handle. AO Quick Couplinq Elastosil small 1 CE 17.08.2005 SPS nla

702905

703667

Bending lron, 4.0mm Locking Set 1 I CE 30.1 1 .2006 VariAx Elbow nla

Screwdriver Blade T10, AO, self retaining b I CE 01.03.2011VariAx Straight

Plaiesnla

703710 Overdrill Guide 6 AE 17.12.2008 VariAx Elbow nla

703716 K-Wire Clamp 1 CE 23.09.2009 VariAx Elbow nla

703820 Drill Guide 2.0mm 6 CE 17.08.2012 VariAx Clavicle nla

703821 Plate-Holding Forceps 6 CE 17.08.2012 VariAx Clavicle nla

703826 Drill Guide 2.6mm b CE 17.08.2012 VariAx Clavicle nla

705121 Plate Trial 5 holes 1 CE 14.06.2013 VariAx 2 nla

705122 Plate Trial 7 holes 1 CE 14.06.2013 VariAx 2 nla

Form Templato DQF 01 -006 Revis¡on: 1.0 PRINTED COPIES FOR REFERËNCE ONLY Page 4 of 25

Trauma & Extremities Form stnyken'TITLE: DECLARATION OF CONFORMITY

VERSION: 4 EFFECTIVE DATE Date of ECN Release

SYSTEM: VariAx 2 RECORD REVISION.. 17

705123 Plate Trial t holes 1 I CE 14.06.2013 VariAx 2 nla

705124 Plate Trial 11 holes 1 I CE 14.06.2013 VariAx 2 nla

705175 Forceps 6 I CE 30.06.2015 VariAx 2 nla

705170 Depth Gauge for TB / T10 Screws þ I CE 30.06.2015 VariAx 2 nla

705291 Periosteal Elevator, Straight Edge 3mm b I CE 11.06.2015 VariAx 2 nla

705292 Periosteal Elevator, Round Edge 3mm 6 l CE 1 1 .06.2015 VariAx 2 nla

705293 Periosteal Elevator, Straight Edge 6mm 6 I CE 1 1 .06.2015 VariAx 2 nla

705294 Periosteal Elevator, Round Edge 6mm b CE '11.06.2015 VariAx 2 nla

705295

705296

705257

94001 5

Periosteal Elevator, Flat Blade 13mm

Periosteal Elevator, Curved Blade 13mm

Straight Reduction Clamp, Broad

o CE 1 1 .06.2015 VariAx 2 nla

6 CE 1 1 .06.2015 VariAx 2 nla

b CE 1 1 .06.2015 VariAx 2 nla

lnstrument lnsert 1 CE 20.o3.2012 VariAx elavicle nla

94001 6

94001 7

Screw Rack 1 CE 20.03.2012 VariAx Clavicle nla

1/3rd Generic lnsert

2/3rd Generic lnsert

1 CE 20.03.2012 VariAx Clavicle nla

94001 I 1 CE 20.03.2012 VariAx Clavicle nla

940024 VariAx Clav Tray 2 Level 1 CE 20.03.2012 VariAx Clavicle nla

703701 Drill, 2.0mm x 122mm, WL50mm, AO-Shaft b lla cE0123 17,12.2008 VariAx Elbow nla

703701 S Drill, 2.0mm x 122mm, WL50mm, AO-Shaft o lla cF-0123 17.12.2008 VariAx Elbow nla

703702 Drill, 2.6mm x 122mm, WL70mm, AO-Shaft 6 lla cE0123 17 12.2008 VariAx Elbow nla

703702S Drill, 2.6mm x 122mm, WL70mm, AO-Shaft 6 lla cE0123 17.12.2008 VariAx Elbow nla

703703 Drill Bit ø2.7mm x 122mm, AO, for 2.7mm Screw 6 lla cE0123 17.12.2008 VariAx Elbow nla

703703S Drill Bit ø2.7mm x122mm, AO, for 2.7mm Screw b lla cE01 23 17.12.2008 VariAx Elbow n/a

703704 Drill Bit ø2.7mm x 122mm, AO, for 3.5mm Screw 6 lla cE01 23 17.12.2008 VariAx.Elbow nla

703704S Drill Bit ø2.7mm x 122mm, AO, for 3.5mm Screw 6 lla c80123 17.12.2008 VariAx Elbow nla

703705

703706

Tap for 2.7mm screws, AO, 70mm o lla cE01 23 17.122008 VariAx Elbow nla

Tap for 3.5mm screws, AO, 70mm 6 cE01 23 17.12.2008 VariAx Elbow nla

70381 B 2mm K-Wire with Stop For T10 Screw Head 6 lla cE0l23 20.03.2012 VariAx Clavicle nla

70381 8S

3901 64

3901 64S

2mm K-Wire with Stop For T10 Screw Head

Kirschner Wire, ø1.6x1 50mm

b lla cE0123 20.o3.2012 VariAx Clavicle nla

I ilb cE0123 17.08.2005 SPS nla

Kirschner Wire, ø1.6x150mm I ilb cE0123 03.05.2007 SPS nla

3901 92 Kirschner Wire, ø2.0x1 50mm a ilb cE0l23 17.08.2005 SPS nla

3901 92S Kirschner Wire, ø2.0x1 50mm I ilb cE0r23 03.05.2007 SPS nla

614508 Locking Screw, T10, 2.7x 9mm Õ ilb cE0123 17.12.2008 VariAx Elbow nla

614508S Locking Screw, T10,2.7x 8mm I ilb cE0123 14.05.2010 VariAx Elbow nla

61 451 0 Locking Screw, T10, 2.7x 1Omm I ilb c80123 17.12.2008 VariAx Elbow nla

61 451 0S Locking Screw, T10, 2.7x 1Omm (t ilb cE0123 14.05.2010 VariAx Elbow nla

614512 Locking Screw, T10, 2.7x 12mrî I ilb cE0123 17j2.2008 VariAx Elbow nla

61451 25 Locking Screw, T10, 2.7x 12mm 0 ilb c80123 14.05.2010 VariAx Elbow nla

614514

6145145

Locking Screw, T10, 2.7x 14mm o ilb cE9123 17.12.2008 VariAx Elbow nla

Locking Screw, T10, 2.7x 14mm 8 ilb cE0123 14.05.20'10 VariAx Elbow nla

614516 Locking Screw, T10, 2.7x 16mm I ilb cE0123 1712.2008 VariAx Elbow nla

61 451 65 Locking Screw, T10, 2.7x 16mm I ilb cE0123 14.05.2010 VariAx Elbow nla

61451 8 Locking Screw, T10, 2.7x 18mm I ilb cE0123 17.12.2008 VariAx Elbow

VariAx Elbow

nla

nla61 451 85

614520

Locking Screw, T10, 2.7x 18mm

Locking Screw, T10, 2.7x20mm

o ilb cE}123 14.05.2010

(t ilb cE0123 17.12.2008 VariAx Elbow nla

614520S Locking Screw, T10, 2.7x20mm Õ ilb cE0123 14.05.2010 VariAx Elbow nla

614522 Locking Screw, T10, 2.7x22mm I ilb cE0123 17.12.2008 VariAx Elbow nla

6145225 Locking Screw, T10, ?..7x 22-mm 0 ilb cE0123 14.05.2010

17.12.2008

VariAx Elbow

VariAx Elbow

nla

nla614524 Locking Screw, T10, 2.7x24mm I ilb cE0123

Form Template.DQF 01-006 Revìsion: 1.0 PRINTED COPIES FOR REFERENCE ONLY Pag6 5 of 25




614524S Locking Screw, T10, 2.7x24mm 8 ilb cE0123 14.05.2010 VariAx Elbow nla

614526 Locking Screw, T10, 2.7x26mm I ilb c80123 17.12.2008 VariAx Elbow nla

614526S Locking Screw, T10, 2.7x26mm I ilb cE0l23 14.05.2010 VariAx Elbow nla

614528 Locking Screw, T10, 2.7x28mm I ilb cE0r23 17.12.2008 VariAx Elbow nla

614528S Locking Screw, T10, 2.7x29mm I ilb cE0123 14.05.2010 VariAx Elbow nla

6'14530

614530S

Locking Screw, T10,2.7x 30mm 8 ilb cE0123 17.12.2008 VariAx Elbow nla

Locking Screw, T10, 2.7x 30mm I ilb cE0123 14.05.2010 VariAx Elbow nla


614532S

614534

61 4534S

Locking Screw, Tl0, 2.7x32mm I ilb c80123 '14.05.2010 VariAx Elbow nla

Locking Screw, T10, 2.7x34mm I ilb cE0123 17.12.2008 VariAx Elbow nla

Locking Screw, T10, 2.7x34mm I ilb cE0123 14.05.2010 VariAx Elbow nla

614608

614608S

Locking Screw, T10, 3.Sx8mm


I ilb cE0l23 17.12.2008 VariAx Elbow nla

I ilb cq.0123 14.05.2010 VariAx Elbow nla

61 461 0 Locking Screw, T10, 3.5x'10mm

Locking Screw, T10, 3.5x1Omm

8 ilb cE0123 17.12.2008 VariAx Elbow nla

61 461 0S

614612

B ilb cE0123 14,05.2010 VariAx Elbow nla

Locking Screw, T10, 3.5x12mm B ilb cE0123 17.12.2008 VariAx Elbow nla

61 46125 Locking Screw, T10, 3.5x12mm I ilb cE0123 14.05.2010 VariAx Elbow nla

614614 Locking Screw, T10, 3.5x14mm 8 ilb cE0123 17.12.2008 VariAx Elbow nla


61 461 6 Locking Screw, T10, 3.5x16mm I ilb cE0123 17.12.2008 VariAx Elbow nla


61 461 I Locking Screw, T10, 3.5x18mm I ilb cE1123 17.12.2008 VariAx Elbow nla

61 461 8S Locking Screw, Tl0, 3.5x18mm 8 ilb cE0123 14.05.2010 VariAx Elbow nla

614620

6146205



I ilb cE0123 17.12.2008 VariAx Elbow nla




614624 Locking Screw, T10, 3.5x24mm I ilb cE0123 17j2.2008 VariAx Elbow nla

6146245

614626

Locking Screw, T10, 3.5x24mm I Ib c80123 14.05.2010 VariAx Elbow nla

Locking Screw, T10, 3.5x26mm 8 ilb cE0l23 17.12.2008 VariAx Elbow nla


614628 Locking Screw, T10, 3.5x28mm I ilb cE0123 17j22008 VariAx Elbow nla


614630 Locking Screw, T10, 3.5x30mm B ilb c80123 17.12.2008 VariAx Elbow nla

614630S Locking Screw, T10, 3.5x30mm I ilb c80123 14.0s.2010 VariAx Elbow nla

614632 Locking Screw, T10, 3.5x32mm



614632S I Ib cE0123 14.05.2010 VariAx Elbow nla

614634

6146345



o ilb cE0123 17.12.2008 VariAx Elbow nla

I ilb cE0'123 14.05.2010 VariAx Elbow nla

614708

61 4708S

Bone Screw, T1 0, 2.7x8mm õ ilb cE0123 17.12.2008 VariAx Elbow nla

Bone Screw, T1 0, 2.7x8mm I ilb c80123 14.05.2010 VariAx Elbow nla

614710 Bone Screw, T10, 2.7x10mm

Bone Screw, T10, 2.7x10mm

I ilb cE0123 17.12.2.008 VariAx Elbow nla

9!710s614712

6147125

B ilb cF.0123 14.05.2010 VariAx Elbow nla

Bone Screw, T 10, 2.7x12mm


I ilb cE0l 23 17.12.2008 VariAx Elbow

I ilb cE0123 14.05.2010 VariAx Elbow n/a

614714 Bone Screw, 110, 2.7x14mm Õ ilb cE0123 17.12.2008 VariAx Elbow nla

6147145 Bone Screw, 110, 2.7x14mm ö ilb cE01 23 14.05.2010 VariAx Elbow nla

614716 Bone Screw, T10, 2,7x16mm I ilb c80123 17.12.2008

r¿¡s ioroVariAx Elbow

VariAx Elbow

nla

nla6l 471 65 Bone Screw, T10, 2.7x16mm I ilb c80123

Form Templats DQF 01-006 Revision: 1.0 PRINTÊD COPIES FOR REFERENCÊ ONLY Page 6 of 25

Trauma & Extremities Form stryken'TITLE: DECLARATION OF CONFORMITY


SYSTEM: VariAx 2 RECORD REVISION', 17

614718 Bone Screw, T10, 2.7x'18mm


Bone Screw, f 1 0, 2.7 x20mm

I ilb cE0123 17.122008 VariAx Elbow nla

61 471 85 I ilb cE01 23 14.05.2010 VariAx Elbow nla

614720

614720S

ilb cE0123 17.12.2008 VariAx Elbow nla

Bone Screw, T 1 0, 2.7 x20mm 8 ilb c80123 14.05.2010 VariAx Elbow nla

614722

6147225

Bone Screw, 110, 2.7x22mm o ltb cE01 23 17.'12.2008 VariAx Elbow nla

Bone Screw, f 10,2.7x22mm I ilb cE01 23 14.05.2010 VariAx Elbow nla

614724 Bone Screw,'1 10, 2.7x24mm I ilb cE0123 17.12.2008 VariAx Elbow nla

614724S Bone Screw, 1 1 0, 2.7 x24mm 0 ilb cE0123 14.05.2010 VariAx Elbow nla

614726

6147265

614728

61 47285

Bone Screw, 1 1 0, 2.7 x26mm I ilb cE0123 17.122008 VariAx Elbow nla

Bone Screw, f 1 0, 2.7 x26mrr' o ilb c80123 14.05.2010 VariAx Elbow nla

Bone Screw, T10, 2.7x28mm I ilb cE0123 17.12.2008 VariAx Elbow nla

Bone Screw, 1 1 0, 2.7 x28mm I ilb cEo123 14.05.2010 VariAx Elbow nla

614730 Bone Screw, T10, 2.7x30mm 8 ilb cE01 23 17.12.2008 VariAx Elbow nla

614730S Bone Screw, T1 0, 2.7x30mm ö ilb cE01 23 14.05.2010 VariAx Elbow nla

614732 Bone Screw, f 10,2.7x32mm I ilb cE0123 17.12.2008 VariAx Elbow nla

6147325 Bone Screw, 110, 2.7x32mm I ilb c80123 14.05.2010 VariAx Elbow nla

614734 Bone Screw, T 1 0, 2.7 x34mm I ilb c80123 17.12.2008 VariAx Elbow nla

61 4734S Bone Screw, f 10,2.7x34mm o ilb cE0123 14.05.2010 VariAx Elbow nla

614808 Bone Screw, T10, 3.5x8mm I ilb cE0123 17.12.2008 VariAx Elbow nla

614808S Bone Screw, T10, 3.Sx8mm I ilb cE0123 14.05.2010 VariAx Elbow nla

61 481 0 Bone Screw, T10, 3.5x10mm ö ilb c80123 17 12.2008 VariAx Elbow nla

61 481 0S Bone Screw, T10, 3.5x10mm I ilb cE0123 14.05.2010 VariAx Elbow nla

614812 Bone Screw, T1 0, 3.5x12mm 8 ilb cE01 23 17.12.2008 VariAx Elbow nla

61 481 25

614814

61 481 45





Bone Screw, T10, 3.5x14mm I ilb cE01 23 14.05.2010 VariAx Elbow nla

61 4816 Bone Screw, T1 0, 3.5x16mm I ilb cE0123 17.12.2008 VariAx Elbow nla


61 481 I61 481 85

Bone Screw, T10, 3.5x18mm 8 ilb c80123 17j22008 VariAx Elbow nla

Bone Screw, T10, 3.5x18mm I ilb cEo123 14.05.2010 VariAx Elbow nla

614820 Bone Screw, T10, 3.5x20mm I ilb cE0123 17j22008 VariAx Elbow nla

614820S Bone Screw, T10, 3.5x20mm I ilb cE0123 14.05.20r 0 VariAx Elbow nla


6148225 Bone Screw, T10, 3.5x22mm 8 ilb cEo123 14.05.2010 VariAx Elbow nla

614824 Bone Screw, T10, 3.5x24mm I ilb cE01 23 17j22008 VariAx Elbow nla

6148245 Bone Screw, T10, 3.5x24mm 0 ilb cE0123 14.05.2010 VariAx Elbow nla


61 48265 Bone Screw, T10, 3.5x26mm ö ilb cEo123 14.05.2010 VariAx Elbow nla

614828 Bone Screw, T10, 3.5x28mm Õ ilb cE01 23 17.12.2008 VariAx Elbow nla

6148285 Bone Screw, T10, 3.5x28mm 8 ltb cE0123 14.05.2010 VariAx Elbow nla

614830 Bone Screw, T1 0, 3.5x30mm


ö ilb c80123 17.12.20A8 VariAx Elbow nla

6148305 B ilb c80123 14.05.2010 VariAx Elbow nla

614832 Bone Screw, T10, 3.5x32mm


Bone Screw, T1 0, 3,5x34mm

Bone Screw, T1 0, 3.5x34mm

I ilb cE01 23 17.12.2008 VariAx Elbow nla

61 4832S

614834


I ilb cE0123 17122008 VariAx Elbow nla

614834S I ilb c80123 14.05.2010 VariAx Elbow nla

61 9905 Washer for Screws ø 2,7mm, ø 3,5mm , ø 4,0mm tt ilb cEo123 15.04.2005 Asnis lll nla

61 99055 Washer for Screws: ø2.713.514.9mm I ilb cE0123 15.04.2005 Asnis lll nla

61 9920 VariAx 2 Washer, T8 & T10 Screws, 2.4mm l2.7mm / 3.5mm Õ ilb cE0123 30.04.2014 Variax 2 nla

Form Tômplate DQF 01-006 Revis¡on: 1.0 PRINTED COPIES FOR REFERËNCE ONLY Pagè1 of 25


VERSION: 4 EFFECTIVE DATE: Date of EGN Release


61 9920S VariAx 2 Washer, T8 & T10 Screws, 2.4mm l2.7mm i 3.5mm I ilb cE0123 13.0'1.20'15 Variax2 nla

626751 Polyaxial Locking Plate Navicular-Cuneiform, Left, Short (T10) I ilb cE0123 26.O5.2014 Variax2 nla

626752 Polyaxial Locking Plate Navicular-Cuneiform, Right, Short (T10) I ilb cE0'123 26.05.2014 Variax2 nla

626753 Polyaxial Locking Plate Navicular-Cuneiform, Left, Long (T10) I ilb cE0123 26.05.2014 Variax 2 nla

626754 Polyaxial Locking Plate Navicular-Cuneiform, Right, Long (T10) I ilb cE01 23 26.O5.2014 Variax 2 nla

626761

626762

Polyaxial Locking Plate Talo-Navicular, Short (T10) B Ib cE0123 26.05.2014 Variax2 nla

Polyaxial Locking Plate Talo-Navicular, Long (T10) I ilb cE0'123 26.05.2014 Variax2 nla

626771

626772

Polyaxial Locking Plate Medial Column Fusion ,Left, Short (T10) I ilb cEo123 26.05.2014 Variax2 nla

Polyaxial Locking Plate Medial Column Fusion, Right, ShortrT10)

a ilb cE1123 26.05.2014 Va¡iax2 nla

626773 Polyaxial Locking Plate Medial Column Fusion, Left, Long (T10) Õ ilb cE0123 26.05.2014 Variax 2 nla

626774Locking Plate Medial Column Fusion, Right, Long

626800 Polyaxial Locking Plate Lateral Column Lengthening, 0mm (T10)

I ilb cE0123 26.05.2014 Variax2 nla


626806 Polyaxial Locking Plate Lateral Column Lengthening, 6mm (T10) I Itb cE0123 26.05.2014 Yariax2 nla

626808 Polyaxial Locking Plate Lateral Column Lengthening, 8mm (T10) 8 ilb c80123 26.05.2014 Variax2 nla

62681 0Polyaxial Locking Plate Lateral Column Lengthening, lOmmff10)

8 ilb cE0123 26.05.2014 Variax 2 nla

626812Polyaxial Locking Plate Lateral Column Lengthening, 12mmtT10)

I ilb cE0123 26.05.2014 Va¡iax2 nla

626880 Polyaxial Locking Plate Talar Neck (T8) I ilb c80123 26.05.2014 Variax2 nla

626881 Polyaxial Locking Plate Navicular, Left (TB) 8 ilb cE0123 26.05.2014 Variax2 nla

626882 Polyaxial Locking Plate Navicular, Right (TB) I ltb cE01 23 26.O5.2014 Yariax2 nla

626885 Polyaxial Locking Plate Cuboid (TB) 0 ilb cE0123 26.05.2014 Yariax2 nla

626751 S Polyaxial Locking Plate Navicular-Cuneiform, Left, Short (T10)

Polyaxial Locking Plate Navicular-Cuneiform, Right, Short (T10)

B ilb cEol23 26.05.2014 Yariax2 nla

6267525 8 ilb cE0123 26.05.2014 Variax 2 nla

626753S Polyaxial Locking Plate Navicular-Cuneiform, Left, Long (T10) B ilb c80123 26.05.2014 Yariax2 nla

626754S

626761 S

Polyaxial Locking Plate Navicular-Cuneiform, Right, Long (T10) o ilb cEo123 26.05.2014 Variax 2 nla

Polyaxial Locking Plate Talo-Navicular, Short (T10) B ilb cE0123 26.05.2014 Variax2 nla

6267625 Polyaxial Locking Plate Talo-Navicular, Long (T10) tt ilb cE0123 26.05.2014 Variax 2 nla

6267715 Polyaxial Locking Plate Medial Column Fusion ,Left, Short (Ï10) I ilb cE0123 26.05.2014 Yariax2 nla

6267725Polyaxial Locking Plate Medial Column Fusion, Right, Shortfi10)


626773S Polyaxial Locking Plate Medial Column Fusion, Left, Long (T10) õ lrb cE0123 26,05.2014 Yariax2 nla

6267745al Locking Plate Medial mn n, ht, Long I ilb c80123 26.05.2014 Variax2 nla

626800s Polyaxial Locking Plate Lateral Column Lengthening, 0mm (T10) B ilb cE0123 26.05.2014 Yariax2 nla

626806S Polyaxial Locking Plate Lateral Column Lengthening, 6mm (T10) 8 ilb cE0123 26.05.2014 Variax2 nla

626808S Polyaxial Locking Plate Lateral Column Lenglhening, Bmm (T10) B ilb cE0123 26.05.2014 Variax2 nla

62681 0SPolyaxial Locking Plate Lateral Column Lengthening, 10mmrT10)

8 ilb cE0123 26.05.2014 Variax2 nla

6268'12S

626BBOS

626881 S

Polyaxial Locking Plate Lateral Column Lengthening, 12mm

[lEPolyaxial Locking Plate Talar Neck (T8)

I ilb cE0123 26.05.2014 Va¡iax2 nla

I ilb cE01 23 26.05.2014 Varia><2 nla

Polyaxial Locking Plate Navicular, Left (T8)

Polyaxial Locking Plate Navicular, Right (TB)

8 ilb c80123 26.05.2014 Yariax2 nla

626882S It ilb c80123 26.05.2014 Variax 2 nla

626BB5S Polyaxial Locking Plate Cuboid (T8) I ilb cE0123 26.05.2014 Va¡iax2 nla

629537 VariAx Compression Plate, broad, 7 holes I ilb cE0123 02.07.2014 Variax 2 nla

629537S VariAx Compression Plate, broad, 7 holes I ilb cE0123 14.06.2013 Yariax2 nla

629548 VariAx Compression Plate, broad, straight, 8 holes 8 ilb cE0123 02.07.2014 Va¡iax2 nla

629548S VariAx Compression Plate, broad, straight, 8 holes I ilb cE0123 14.06.2013 Variax 2 nla

629547 VariAx Compression Plate, broad, straight, 7 holes B ilb cEo123 02.07.2014 Yariax2 nla

629547S VariAx Compression Plate, broad, straight, 7 holes 8 ilb cE0123 14.08.2013 Variax2 nla

Form Template DQF 01-006 Revision: 1.0 PRINTED COPIÊS FOR REFERENCE ONLY Page 8 of 25



SYSTEM: VariAx 2 RECORD REVISION. 17

629546 VariAx Compression Plate, broad, straight, 6 holes I ilb c80123 02.07,2014 Yariax 2 nla

629546S VariAx Compression Plate, broad, straight, 6 holes I ilb cE0l23 14.06.2013 Yariax2 nla

629545 VariAx Compression Plate, broad, straight, 5 holes I ilb cE0123 02.07.2014 Variax 2 nla

629545S VariAx Compression Plate, broad, straight, 5 holes 8 ilb c80123 14.06.2013 Varias<2 nla

629544 VariAx Compression Plate, broad, straight, 4 holes I ilb cE0123 02.07.2014 Variax 2 nla

629544S

629543

VariAx Compression Plate, broad, straight, 4 holes I ilb cE0123 14.06.2013 Variax2 nla

VariAx Compression Plate, broad, straight, 3 holes I ilb c80123 02.07.2014 Variax2 nla

629543S

629542

VariAx Compression Plate, broad, straight, 3 holes õ ilb c80123 14.06.2013 Varia¡< 2 nla

VariAx CompressionPlate, broad, straight, 2 holes I ilb cE0123 02.07.2014 Variax 2 nla

629542S VariAx Compression Plate, broad, straight, 2 holes 8 Ib cE1123 14.06.2013 Yariax2 nla

629570 VariAx Compression Plate, broad, curved, 20 holes I ilb cE0123 02.07.2014 Variax2 nla

629570S VarìAx Compression Plate, broad, curved, 20 holes 8 ilb cE0123 14.06.2013 Variax 2 nla

629568 VariAx Compression Plate, broad, curved, 18 holes B ilb cE0123 02.07.2014 Variæ<2 nla

629568S VariAx Compression Plate, broad, curved, 18 holes I ilb c80123 14.06.2013 Variax2 nla

629566 VariAx Compression Plate, broad, curved, 16 holes 8 ilb cE0123 02.07.2014 Variax 2 nla

bzv5bbù

629564

629564S

VariAx Compression Plate, broad, curved, 16 holes I ilb cE0123 14.06.2013 Yariax 2 nla

VariAx Compression Plate, broad, curved, 14 holes tt ilb cE0123 02.07.2014 Yariax2 nla

VariAx Compression Plate, broad, curved, 14 holes I ilb cE0123 14.06.2013 Varia>< 2 nla

629562

ozss62s

629561

VariAx Compression Plate, broad, curved, 12 holes

VariAx Compression Plate, broad, curved, 12 holes

B ilb cE0123 02.07.2014 Yariax2 nla

o ilb c80123 14.06.2013 Variax 2 nla

VariAx Compression Plate, broad, curved, 11 holes I ilb cE0123 02.07.2014 Variax 2 nla

629561 S VariAx Compression Plate, broad, curved, 11 holes 0 ilb c80123 14.06.2013 Yariax2 nla

629560 VariAx Compression Plate, broad, curved, 10 holes tt ilb cE0123 02.07.2014 Variax2 nla

629560S

629559

VariAx Compression Plate, broad, curved, 10 holes I ilb cE0123 14.06.2013 Variax2 nla

VariAx Compression Plate, broad, curved, t holes I Ib cE0123 02.07.2014 Variax 2 nla

6295595 VariAx Compression Plate, broad, curved, t holes I ilb cE0123 14 06.2013 Variax2 nla

62951 0 VariAx Compression Plate, narrow, slraight, 10 holes Õ ilb cEo123 02.07.2014 Variax2 nla

62951 0S VariAx Compression Plate, narrow, straight, 10 holes I Ib cE0123 14.06.20't 3 Variax2 nla

629509 VariAx Compression Plate, narrow, straight, t holes I ilb cE0123 02.07.2014 Variax2 nla

629509S VariAx Compression Plate, narrow, straight, t holes (t ilb c80123 14.06.2013 Variax 2 nla

629508 VariAx Compression Plate, narrow, straight, I holes Õ ilb cE0123 02.07.2014 Variax 2 nla

629508S VariAx Compression Plate, narrow, straight, I holes I Ib cE0123 14.06.2013 Variax2 nla

629507 VariAx Compression Plate, narrow, straight, 7 holes I ilb cE0123 02.07.2014 Variax 2 nla

629507S VariAx Compression Plate, narrow, straight, 7 holes I ilb cE0123 14.06.2013 Variax2 nla

629506 VariAx Compression Plate, narrow, straight, 6 holes I ltb cE0123 02.07.2014 Varia><2 nla

629506S VariAx CompressionPlate, narrow, straight, 6 holes Õ ilb cE9123 14.06.2013 Variax2 nla

629505 VariAx Compression Plate, narrow, straight, 5 holes I ilb c80123 02.07.2014 Yaria>< 2 nla

629505S VariAx Compression Plate, narrow, straight, 5 holes

VariAx Compression Plate, narrow, straight, 4 holes

I Ib cE0123 14.06.2013 Variax2 nla

629504

629504S

I ilb cE0123 02.07.2014 Yariax2 nla

VariAx Compression Plate, nanow, straight, 4 holes I ilb cE0123 14.06.2013 Vatiax2 nla

629503

629503S

VariAx Compression Plate, narrow, straight, 3 holes I ilb cE0123 02.07.2014 Variax 2 nla

VariAx Compression Plate, narrow, straight, 3 holes 8 ilb cE0123 14.06.2013 Va¡iax2 nla

629502 VariAx Compression Plate, narrow, straight, 2 holes I ilb c80123 02.07.2014

14.06.2013

Variax2

Yariax2

nla

nla629502S

629527

VariAx Compression Plate, narrow, straight, 2 holes 8 ilb c80123

VariAx Compression Plate, narrow, straight, 7 holes I ilb c80123 02.07.2014 Yariax2 nla

629527S VariAx Compression Plate, narrow, straight, 7 holes I ilb cE0123 14.06.2013 Variax2 nla

656008

656008S

65601 0

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm / LBmm 8 ilb cE0123 3A.04.2014 Variax 2 nla

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm / LSmm B ilb cE0123

c80123

1 3.01 .2015

30.04.2014

Variax2va¡Ài"z

nla

YariAx2 Locking Screw, T8, Full Thread, 2.4mm lL10mm I ilb nla

Form T€mplate DQF 01-006 Revision: 1.0 PRINTED COPIES FOR REFERENCE ONLY Pâge I of 25

Trauma & Extremities Form stnyl<en'TITLE: DECLARATION OF CONFORM ITY



65601 0S VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL10mm ilb cE0123 13.01 .2015 Variax2 nla

65601 2 VariAx 2 Locking Screw, TB, Full Thread, 2.4mm lL12mm

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL12mm

8 ilb cE0123 30.04.2014 Variax 2 nla

65601 25

656014

I ilb cE0123 1 3.01 .2015 Yariax2 nla

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL14mm I ilb cE0123 30.04.2014 Variax 2 nla

656014S

656016

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL14mm a ilb cF-9123 13.01 .2015 Variax2 nla

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL16mm I ilb cE0123 30.04.2014 Variax 2 nla

65601 ôS

65601 B

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL16mm I ilb cE0123 13.01.2015 Variax2 nla


65601 8S VariAx 2 Locking Screw, TB, Full Thread, 2.4mm lL18mm I ilb cE0123 13.01 .2015 Variax 2 nla

656020 VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL20mm ö ilb c80123 30.04.2014 Variax 2 nla

656020S VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL20mm I ilb cE0123 13.01.2015 Variax 2 nla

656022 VariAx 2 Locking Screw, TB, Full Thread, 2.4mm lL22mm B ltb c80123 30.04.2014 Varia><2 nla

656022S VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL22mm I ilb cE0123 13.01 .2015 Variax2 nla

656024 VariAx2 Locking Screw, T8, Full Thread, 2.4mm lL24mm I ilb cE0123 30.04.2014 Variax2 nla

656024S VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL24mm I ilb cE0123 13.01 .2015 Variax2 nla

656026

656026S



8 ilb cEo123 30.04.2014 Variax 2 nla

8 ilb cE0123 1 3.01 .2015 Yariax2 nla

656028 VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL28mm 8 ilb cE0123 30.04.2014 Variax2 nla

656028S VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL28mm B ilb cE0123 13.01 .2015 Variax2 nla

656030 VariAx 2 Locking Screw, TB, Full Thread, 2.4mm lL30mm o ilb cE0123 30.04.2014 Variax2 nla

656030S

656032

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL30mm Õ ilb cE0123 13.01.2015 Va¡iax2 nla


VariAx 2 Locking Screw, TB, Full Thread, 2.4mm lL32mm


656032S

656034

I üb cE0123 13.01 .2015 Va¡iax2 nla

VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL34mm B ilb cE0123 30.04.2014 Variax 2 nla

656034S VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL34mm Õ ilb cE0123 13.01.2015 Variax 2 nla

656036 VariAx 2 Locking Screw, T8, Full Thread, 2Amm lL36mm



656036S B ilb cE0123 13.01 .2015 Variax2 nla

656038 VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL38mm I ilb cE0123 30.04.2014 Yariax2 nla

656038S VariAx 2 Locking Screw, T8, Full Thread, 2.4mm lL3Bmm I ilb c80123 1 3.01 .2015 Va¡iax2 nla

6561 08 VariAx 2 Bone Screw, TB, Full Thread, 2.4mm i LBmm I ilb cE0123 30.04.2014 Yariax2 nla

6561 08S VariAx 2 Bone Screw, T8, Full Thread, 2.4mm / LSmm B ilb cE0123 13.01 .2015 Yariax2 nla

6561 10

6561 1 0S

VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL10mm I ilb cE0123 30.04.2014 Variax 2 nla

VariAx2 Bone Screw, T8, Full Thread, 2.4mm lL10mm I ilb cE0123 13.01.20't5 Yariax2 nla

656112

6561 125

VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL12mm I ilb cE0123 30.04.2014 Yariax2 nla

VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL12mm 8 ilb cE0123 13.01 .2015 Yariax2 nla

6561 14

6561 145

6561 1 6

osoìroi6561 1 B

VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lLl4mm I ilb c80123 30.04.2014 Variax2 nla

VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL14mm I ilb cE01 23 13.01.2015 Variax2 nla

VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL16mm I ilb cE0123 30.04.2014 Variax2 nla

VariAx 2 Bone Screw, TB, Full Thread, 2.4mm lL16mm I ilb cE0123 13.01 .2015 Yariax2 nla

VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lLlSmm I ilb cE0123 30.04.2014 Variax2 nla

6561 1 85 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL18mm I ilb cE0123 13.01.2015 Yariax2 nla

656120 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL20mm I ilb cE0123 30.04.2014 Variax 2 nla

6561 20S VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL20mm I ilb cE0123 1 3.01 .2015 Vatiax2 nla

nla656122 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL22mm

VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL22mm

B ilb c80123 30.04.2014 Variax2

6561 22S I ilb cE0123 13.01.2015 Variax 2 nla

656124 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL24mm


Õ ilb cE0123 30.04.2014 Variax2 nla

656124S I ilb cE0123 13.01 .20'15 Variax 2 nla

6561 26 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL26mm I ilb cE0123 30.04.2014 Yariax2

Yariax2

nla

nlaVariAx 2 Bone Screw, TB, Full Thread, 2.4mm lL26mm I ltb c80123 13.01 .20156561 26S


Trauma & Extremrties Form stnyken'TITLE: DECLARATION OF CONFORMITY


SYSTEM VariAx 2 RECORD REV¡SION: 17

6561 28 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL28mm 8 ilb cE01 23 30.04.2014 Yariax2 nla

6561 28S VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL28mm I ilb c80123 13.01 .2015 Variax2 nla

6561 30 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL30mm I ilb cE0123 30.04.2014 Variax2 nla

6561 30S VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL30mm Õ ilb cEo123 13.0r .2015 Variax2 nla

6561 32 VariAx 2 Bone Screw, TB, Full Thread, 2.4mm lL32mm I ilb cE01 23 30.04.2014 Variax2 nla

6561 32S VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL32mm I ilb cE0't23 13.01 .2015 Yariax2 nla

6s61 34 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL34mm I ilb cE0'123 30.04.2014 Variax 2 nla

6561 34S VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL34mm I ilb cE0123 13.01 .2015 Variax2 nla

6561 36 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL36mm B ilb c80123 30.04.2014 Variax2 nla

6561 365 VariAx 2 Bone Screw, T8, Full Thread, 2.4mm lL36mm 8 ilb cE0123 r 3.01 .2015 Vatiax2 nla

6561 38 VariAx2 Bone Screw, T8, Full Thread, 2.4mm lL38mm


tt ilb cE0123 30.04.2014 Variax2 nla

6561 38S 8 ilb cE01 23 13.0't .2015 Variax 2 nla

656308 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm / LBmm I ilb cE0123 30.04.2014 Variax2 nla

656308S VariAx 2 Locking Screw, T8, Full Thread, 2.7mm / LSmm a ilb cE0'123 13.01.2015 Variax2 nla

65631 0 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL1Omm I ltb c80123 30.04.2014 Variax 2 nla

65631 0S VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL10mm I ilb cE0123 13.01 .2015 Yariax2 nla

656312 VariAx 2 Locking Screw, TB, Full Thread, 2.7mm lL12mm I ilb cE0123 30.04.2014 Variax2 nla

65631 25 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL12mm I ilb cE0123 13.01 .2015 Yariax2 nla

656314 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL14mm I ilb c80123 30.04.2014 Variax2 nla

65631 4S VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL14mm I ilb cE0123 13.01.2015 Variax 2 nla

656316

656316S

65631 8


VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL16mm ö ilb c80123 13.01 .2015 Variax2 nla

VariAx 2 Locking Screw, TB, Full Thread, 2.7mm lL18mm B ilb c80123 30.04.2014 Va¡iax2 nla

65631 BS

656320

VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL18mm I ilb cE0'123 13.01 .2015 Varia¡<2 nla


656320S VariAx 2 Locking Screw, T8, Full Thread, 2.7mm I L20mm I ilb cE0123 13.01 .2015 Variax2 nla

656322 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL22mm 8 ilb c80123 30.04.2014 Yariax2 nla

656322S VariAx 2 Locking Screw, TB, Full Thread, 2.7mm lL22mm 8 ilb cE0123 13.01 .2015 Yariax2 nla

656324 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL24mm õ ilb cE0123 30.04.2014 Va¡iax2 nla

656324S VariAx 2 Locking Screw, TB, Full Thread, 2.7mm lL24mm Õ ilb cE0123 1 3.01 .2015 Variax2 nla

656326 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL26mm I ilb cEo123 30.04.2014 Variax2 nla

656326S VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL26mm B ilb c80123 13.01 .2015 Variax 2 nla

6s6328

656328S

656330

VariAx 2 Locking Screw, TB, Full Thread, 2.7mm lL2Bmm 8 ilb c80123 30.04.2014 Variax2 nla

VariAx 2 Locking Screw, T8, Full Thread, 2.7mm I L28mm Õ ilb cE0123 13.0't .2015 Variax 2 nla


656330S

656332

656332S


VariAx 2 Locking Screw, T8, Full Thread, 2.7mm I L32mm

I ilb cE01 23 13.01 .201 5 Variax 2 nla

I ilb cE0123 30.04.2014 Variax 2 nla

VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL32mm B ilb cEol23 13.01 .2015 Vatiax2 nla

656334 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL34mm o ilb cE0123 30.04.2014 Variax2 nla

656334S VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL34mm 8 ilb cE0123 13.01 .2015 Variæ<2 nla

656336 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm I L36mm B ilb cE0123 30.04.2014 Varia><2 n/a

656336S YariAx2 Locking Screw, T8, Full Thread, 2.7mm lL36mm ö ilb cEo123 13.01 .2015 Variæ<2 nla

656338 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL3Bmm I Ib cE01 23 30.04.2014

13.01 .2015

Yariax 2

Variax2

nla

nla656338S

656340

Variþa 2 Locking Screw, T8, Full Thread, 2.7mm I L38mm I ilb cE0123


656340S

656345



I ilb cE0123 13.01 .201 5 Yariax2 nla

I ilb c80123 30.04.2014 Variax 2 nla

656345S VariAx 2 l,ocking Screw, T8, Full Thread, 2.7mm lL45mm Õ ilb cE0123

cE0123

13.01 .2015

30.04.2014

Variax2V^r'ruZ

nla

656350 VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL50mm 0 ilb nla

Form Template DQF 01-006 Revisìon: 1.0 PRINTED COPIES FOR REFERÊNCÊ ONLY Page11of25



SYSTEM: VariAx 2

656350S VariAx 2 Locking Screw, T8, Full Thread, 2.7mm lL50mm

VariAx 2 Bone Screw Full Thread 2.7mm / LSmm

656408S

65641 0

RECORD REV¡SION: 17

B ilb cE0123 13.01.2015 Variax2 nlaa ilb c80123 30.04.2014 Yariax2 nla

VariAx 2 Bone Screw. TB. Full Thread, 2.7mm / LBmm 8 ilb cE0123 1 3.01 .2015 Variax2 nla

VariAx 2 Bone Screw, TB, Full Thread, 2.7mm lL1Omm I ilb cE0123 30.04.2014 Variax2 nla

65641 0S

656412

VariAx 2 Bone Screw, TB, Full Thread, 2.7mm lL1Omm B ilb cE0123 13.01.2015 Yariax2 nla

VariAx 2 Bone Screw, T8, Full Thread, 2.7mm I Ll2mm al ilb c80123 30.04.2014 Yariax2 nla

65641 2S VariAx 2 Bone Screw. T8. Full Thread, 2.7mm lL12mm I ilb cE0123 13.01.2015 Variax 2 nla

656414 VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL14mm 0 ilb cE0123 30.04.2014 Variax2 nla

6564145

65641 6

VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL14mm tt ilb cE0123 13.01.2015 Yariax2 nla

VariAx 2 Bone Screw, T8, Full Thread, 2.7mm I L16mm I ilb cE0123 30.04,2014 Variax 2 nla


65641 I VariAx 2 Bone Screw. T8, Full Thread, 2.7mm lLlSmm I ilb cE0123 30.04.2014 Variax2 nla

6564 VariAx 2 Bone Screw. T8, Full Thread, 2.7mm lL18mm ö ilb cE0123 1 3.01 .2015 Yariax2 nla

656420 VariAx 2 Bone Screw, TB, Full Thread, 2.7mm lL20mm I ilb cE9123 30.04.2014 Variax2 nla

656420S

656422

VariAx 2 Full Thread 2.7mm lL20mm Õ ilb cE0 t23 13.01.2015 Variax 2 nla

VariAx2 Bone Screw, T8, Full Thread, 2.7mm lL22mm I ilb cE0123 30.04.2014 Variax2 nla

6564225

6.æ4U

656424S

VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL22mm B ilb cE0123 r 3.01.2015 Variax2 nla

VariAx 2 Bone Screw. T8. Full Thread .2.7mm lL24mm

VariAx 2 Bone Screw. T8, Full Thread, 2.7mm lL24mm


8 ilb cE0l23 13.01.2015 Variax2 nla

656426

656426S

VariAx 2 Bone Screw. T8. Full Th 2.7mm lL26mm




656428 VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL28mm I ilb cE0123 30.04.2014 Variax2 nla

656428S VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL28mmo ilb cE0123 13.01.2015 Variax2 nla

656430 VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL30mm I ilb c80123 30.04.2014 Variax2 nla

656430S VariAx2 Bone Screw. T8. Full Thread, 2.7mm lL30mm I ilb cE0123 13.01.2015 Variax2 nla

656432 2 Bonê Screw Full Thread 2.7mm lL32m I ilb cE0123 30.04.2014 Variax2 nla

656432S VariAx 2 Bo Full Thread 2.7mm lL32mm I ilb cEo123 13.01.2015 Variax2 nla

656434 VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL34mm o ilb cE0123 30.04.2014 Variax2 nla

656434S VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL34mm 8 ilb cÊ0123 13.01.2015 Variax2 nla


656436S VariAx 2 Bone Screw, TB, Full Thread, 2.7mm lL36mm 8 ilb cE0123 13.01.2015 Variax 2 nla

656438

656438S

Vari\x2 Bone Screw, TB, Full Thread, 2.7mm lL38mm I ilb cE0123 30.04,2014 Yariax2 nla

VariAx 2 Bone Screw, T8, Full Thread, 2.7mm lL38mm 8 ilb c80123 13.01.2015 Variax 2 nla

656440

656440S


2 Bone Screw Full Thread 2.7mm I Õ ilb cE0123 13.01.2015 Variax2 nla

656445 VariAx 2 crew Full Th 2.7mm lL45mm I ilb cE0123 30.04.2014 Variax2 nla

6564455 VariAx 2 Bone S Full 2.7mm lL45mm ö ilb cE0123 13.01.2015 Variax2 nla


656450S YariAx2 Bone Screw. T8, Full Thread, 2.7mm lL50mm 0 ilb c80123 13.01.2015 Variax2 nla

65651 6 VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL16mm a ilb cE1123 30.04.2014 Yariax 2 nla

65651 65 VariAx 2 Bone Screw, TB, Partial Thread, 2.7mm lL16mm I ilb cE0123 13.01.2015 Variax2 nla

65651 I VariAx 2 Bone Screw, TB, Partial Thread, 2.7mm lL18mm 8 ilb cEo123 30.04.2014 Variax2 nla

65651 8S VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL18mm I ilb cqo123 13.01 .2015 Yaria><2 nla

656520

656520S

VariAx 2 Bone Screw, T8, Partial Thread, 2,7mm lL20mm

VariAx 2 Bone Screw, TB, Partial Thread, 2.7mm lL20mm u

ilb cE0123 30.04.2014 Variat< 2 nla

ilb cE0123 30.04.2014 Variax2 nla

656522 VariAx2 Bone Screw, TB, Partial Thread, 2.7mm ll22mm I ilb cE0123 30.04.2014 Yariax 2 nla

656522S VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL22mm I ilb cE0123 30.04.2014 Variax2 nla

656524

6565245

VariÂx 2 Bone Screw, T8, Partial Thread, 2.7mm lL24mm tt ilb c80123 30.04.2014 Yariax2 nla

VariAx 2 Bone Screw, TB, Partial Thread, 2.7mm ll24mm I ilb cE0123 13.01 .201 5 Variax 2 nla

Form Template DQF 01-006 Revision: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page 12 oî 25

Trauma & Extremities Form stryken"TITLE: DECLARATION OF CONFORMITY

VERSION 4 EFFECTIVE DATE: Date of EcN Release

SYSTEMI VariAx 2

656526

656526S

656528

656528S

VariAx 2 Screw, T10, Full Thread, 2.7mm lL22mm


657024 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL24mm

RECORD REVISION: 17

VariAx 2 Bone Screw, TB, Partial Thread, 2.7mm lL26mm

VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm ll26mm

VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL28mm

VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm ll29mm


8 ilb cE0123 13.01 .2015 Variax 2 nla

o ilb c80123 30.04.2014 Variax 2 nla

I ilb cE0123 13.01 .2015 Yariax2 nla

656530 VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm / L30mm I ilb cFg123 30.04.2014 Variax2 nla

656530S

656532

VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL30mm I ilb cE0123 13.01 .2015 Varia><2 nla

VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL32mm I ilb cE0l23 30.04.2014 Variax 2 nla

656532S VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL32mm I ilb c80123 13.01.2015 Varias<2 nla

656534 VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm / L34mm

VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL34mm


656534S I ilb cE0l23 13.01 .2015 Yariax2 nla

656536 VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL36mm Õ ilb cE0123 30,04.2014 Va¡iax2 nla

656536S VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm / L36mm I Ib cE0123 13.01 .2015 Variax 2 nla

656538

656538S

VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL38mm tt ilb c80123 30.04.2014 Variax2 nla

VariAx 2 Bone Screw, TB, Partial Thread, 2.7mm lL38mm I ilb cE0123 1 3.01 .2015 Vatiax 2 nla

656540 VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL40mm I ilb cE0123 30,04.2014 Variax2 nla

656540S

65661 6

65661 6S

65661 I

VariAx 2 Bone Screw, T8, Partial Thread, 2.7mm lL40mm ö ilb cE0123 13.01 .2015 Variax2 nla

VariAx 2 Locking Peg, T8, 2.0mm i L16mm I ilb cE0123 30.04.2014 Variax2 nla

VariAx2 Locking Peg, T8, 2.0mm / L16mm

VariAx 2 Locking Peg, T8, 2.0mm / L18mm

VariAx 2 Locking Peg, TB, 2.0mm lLlBmm

B ilb cE0123 13.01 .2015 Variax2 nla


65661 8S I ilb cEo123 13.01.2015 Yariax2 nla

656620 VariAx 2 Lockin Peg, T8, 2.0mm / L20mm o ilb cE0123 30.04.2014 Va¡iax2 nla

656620S VariAx 2 Locking Peg, T8, 2.0mm lL20mm I ilb cE0123 13.01 .2015 Variax2 nla

656622 VariAx 2 Locking Peg, T8, 2.0mm / L22mm I ilb cE0123 30.04.2014 Variax 2 nla

656622S VariAx 2 Locking Peg, T8, 2.0mm lL22mm tt ilb cE0'123 13.01 .2015 Variax 2 nla

656624 VariAx 2 Locking Peg, T8, 2.0mm / L24mm I ilb c80123 30.04.2014 Variax2 nla

6566245 VariAx 2 Locking Peg, TB, 2.0mm lL24mm I ilb c80123 1 3.01 .2015 Variax2 nla

656626 VariAx 2 Locking Peg, T8, 2.0mm / L26mm ö ilb cE0123 30.04.2014 Variax2 nla

656626S VariAx 2 Locking Peg, T8, 2.0mm lL26mm I ilb cEo123 13.01 .2015 Variax2 nla

656628 VariAx 2 Locking Peg, T8, 2.0mm / L28mm

VariAx 2 Locking Peg, T8, 2.0mm / L28mm

I ilb cE0123 30,04.2014 Variax2 nla

656628S

656630


VariAx 2 Locking Peg, T8, 2.0mm lL30mm I ilb cE0123 30.04.2014 Va¡iax2 nla

656630S VariAx 2 Locking Peg, TB, 2.0mm / L30mm I ilb c80123 13.01 .2015 Variax2 nla

657008 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / LSmm B ilb cE0123 30.04.2014 Variax2 nla

657008S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / LBmm I ilb cE0123 13.01 .2015 Yariax2 nla

65701 0 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL1Omm I ilb cE0123 30.04.2014 Variax2 nla

65701 0S VariAx 2 Locking Screw, Tl0, Full Thread, 2.7mm lL10mm 8 ilb cE0123 13.01 .2015 Yariax2 nla

657012 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL12mm 8 Ib cE0123 30.04.2014 Va¡iax2 nla

65701 2S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL12mm 8 ilb cE0r23 13.0r .2015 Variax 2 nla

657014 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL14mm I ilb cE0123 30.04.2014 Variax2 nla

657014S VariAx 2 Locking Screw, T10, Full Thread, 2,7mm lL14mm ö ilb c80123 13.01 .2015 Variax2 nla

657016 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L16mm I ilb c80123 30.04.2014 Variax2 n/a

65701 65 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL16mm I ilb cE0123 13.01.2015 Variax2 nla

65701 I VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL18mm I ilb cE0123 30.04.2014 Variax2 nla

65701 8S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL18mm


8 ilb cE0123 13.01 .2015 Variax2 nla

657020 B ilb cE0123 30.04.2014 Variax 2 nla

657020S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL20mm (t ilb cE0123 13.01 .2015 Variax2 nla

657022 I ilb cE0123 30.04.2014 Variax2 nla

657022S I ilb cE0123 13.01 .201 5 Variax 2 nla


Form Template DQF 01-006 Revis¡on: 1.0 PRINTËD COPIES FOR REFERENCE ONLY Page 13 of 25

Trauma & Extremities Form stnyl<en"TITLE: DECLARATION OF CONFORMITY


SYSTEM: VariAx 2

657024S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL24mm

657026 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL26mm

657026S

657028

REGORD REVISION 17


I ilb c80123 30.04.2014 Variax2 nla




Õ ilb cE0'123 30.04.2014 Variax2 nla

657028S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL2Bmm B ilb cE0123 '13.01 .20r 5 Variax2 nla

657030 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L30mm ilb cE0123 30.04.2014 Variax2 nla

657030S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL30mm I ilb cE0123 13.01.2015 Ya¡iax2 nla

657032 VariAx2 Locking Screw, T10, Full Thread, 2.7mm lL32mm I Ib cF-1123 30.04.2014 Variax2 nla

657032S VariAx 2 Locking Screw, Tl0, Full Thread, 2.7mm lL32mm 8 ilb cE0123 r 3.01 .2015 Variax2 nla

657034 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L34mm I ilb cE0123 30.04.2014 Variax2 nla

657034S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL34mm Õ ilb cE0l23 13.01 .201 5 Va¡iax 2 nla

657036

657036S

VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L36mm I ilb c80123 30.04.2014 Variax2 nla

VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L36mm ö ilb cE0123 13.01 .2015 Yariax2 nla

657038

657038S

657040

657040S

VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL3Bmm B ilb cE0123 30.04.2014 Variax 2 nla

VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L38mm



B ilb cE0'123 13.01 .2015 Yariax2 nla

ö ilb cE0123 30.04.2014 Variax2 nla

ilb c80123 13.01 .2015 Variax2 nla

657042 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL42mm I ilb cE0123 30.04.2014 Va¡iax2 nla

657042s VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL42mm I ilb cE0123 13.01.2015 Yariax2 nla

657044 VariAx 2 Locking Screw, T10, Full Thread, 2,7mm lL44mm 8 ilb cE0123 30.o4.2014 Variax 2 nla

657044s VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL44mm I ilb cE0123 13.01 .201 5 Va¡iax,2 nla

6s7046 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL46mm I ilb cE0l23 30.04.2014 Variax 2 nla

657046S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL46mm ö ilb cE0r23 13.01 .20'15 Variax2 nla

657048 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm ll43mm I ilb cE0123 30.04.2014 Variax2 nla

657048S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL48mm 8 ilb cE0123 13.01 .201 5 Variax 2 nla

657050

657050s

VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L50mm I ilb cEo123 30.04.2014 Variat<2 nla

VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L50mm I ilb cE0123 13.01 .2015 Variax2 nla


657055S YariAx 2 Locking Screw, T10, Full Thread, 2.7mm I L55mm 8 ilb cE0123 13.01 .2015 Variax 2 nla

657060 VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L60mm I ilb c80123 30.04.2014 Varia><2 nla

657060S VariAx 2 Screw, T10, Full Thread, 2.7mm lL60mm I ilb cE0123 13.01.2015 Va¡iax2 nla


657065S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm / L65mm I ilb cE0123 r 3.01 .2015 Variax2 nla


657070S VariAx 2 Locking Screw, T10, Full Thread, 2.7mm lL70mm I ilb cE0123 13.01.2015 Variax 2 nla

6571 08 VariAx 2 Bone Screw T1 Full 2.7mm / LSmm I ilb cE01 23 30.04.2014 Variax2 n/a

6571 085 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm / LBmm 8 ilb cE0123 13.01 .2015 Yariax2 nla

6571 1 0 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL1Omm I ilb cE0123 30.04.2014 Variax2 nla

6571 10S VariAx 2 Bone Screw. T10, Full Thread, 2.7mm / L1Omm I ilb cE01 23 1 3.01 .2015 Variax2 nla

657112 2 Bone Screw T1 Full Th 2 lL12mm I llb cE0123 30.04.2014 Variax 2 nla

6571 I 25 VariAx 2 Screw T10 Full Th 2.7mm I 2 I ilb cE0123 13.01.20'15 Variax2 nla

657114 Vari{x2 T10 Full Thread 2.7mm ll I ilb cE01 23 30.04.2014 Variax 2 nla

6571 1 45 VariAx 2 T10 Full Thread 2.7mm I m I ilb cE0123 1 3.01 .2015 Variax2 nla

657116

6571 1 65

VariAx 2 T10 Full Thread, 2.7mm I m

VariAx 2 T1 Full Thread 2.7mm lL m


I ilb cE0123 13.O1.2015 Variax 2 nla

6571 1 I6571 1 85

VariAx 2 T1 Full Thread 2.7mm ll m Õ ilb c80123 30.04.2014 Va¡iax2 nla

VariAx 2 Bone T1 Full Thread 2.7mm I 1 I ilb cE0123 1 3.01 .2015 Variax2 nla

657120

6571 20S

VariAx 2 Bone T1 Full 2.7mm ll-2 I ilb cF-9123 30.04.2014 Variax2

Variax2

nla

nlaYariAx2 Bone Screw, T10, Full Thread, 2.7mm lL204m

-o ilb cE0123 13.01.2015

Form Template DQF 01-006 Revis¡on: 1.0 PRINTÉD COPIES FOR REFERENCE ONLY Page 14 of 25

Trauma & Extremities Form stnyl<en'TITLE DECLARATION OF CONFORMITY

VERSION: 4 EFFECT¡VE DATE Date of EGN Release

SYSTEM: Vari,Ax 2

VariAx 2 Bone T10 Full Thread 2.7mm lL22mm

VariAx 2 T10 Full Thread 2.7mm iL22mm

RECORD REVISION 17

7122 I ilb cE0123 30.04.2014 Variax2 nla

6571225 8 Ib c80123 13.01 .2015 Yariax2 nla

657124 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm ll24mm I ilb cE0123 30.04.2014 Variax2 nla

6571245 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL24mm at ilb c80123 1 3.01 .2015 Variax2 nla

657126 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL26mm I ilb cE01 23 30.04.2014 Variax2 nla

6571 26S VariAx 2 Bone Screw. T10. Full Thread, 2.7mm ll26mm ltb cE0123 13.01.2015 Variax2 nla

657128 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm / L28mm ö ilb cE0123 30.04.2014 Ya¡iax2 nla

6571 28S VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL28mm 8 ilb cE01 23 13.01 .2015 Variax 2 nla

657'130 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL30mm B ltb cE0123 30.04.2014 Yariax2 nla

6571 30S YariAx2 Bone Screw, T10, Full Thread, 2,7mm / L30mm I ilb cE0123 13.01.2015 Va¡iax2 nla

657132 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL32mm I ilb cE0123 30.04.2014 Variax 2 nla

6571!?e

657134

VariAx 2 Bone Screw. T10. Full Th reaci 2.7mm I L32mm

VariAx 2 Bone Screw. Tl0, Full Thread, 2.7mm lL34mm

I ilb cE0l 23 13.01 .2015 Variax2 nla

Õ Ib cE0123 30.04.2014 Variax2 nla

6571 34S VariAx 2 Bone Screw, T10, Full Thread, 2.7mm / L34mm


I ilb c80123 13.01.2015 Variax2 nla

6571 36

6571 36S

8 ilb c80123 30.04.2014 Variax2 nla



6571 38S VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL38mm õ ilb cE0123 13.01 .2015 Variax2 nla

657140 VariAx 2 Bone Screw. T10, Full Thread, 2.7mm lL40mm 8 ilb cE0123 30.04.2014 Variax 2 nla

657140S 2 Bone Screw T1 Full Thread 2.7mm lL40mm I ilb cE0123 13.01.2015 Variax 2 nla

657142 VariAx 2 Bone T1 Full Thread 2.7mm ll42mm o ilb cE0123 30.04.2014 Variax 2 nla

6571425 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL42mm I ltb cE0123 13.01.2015 Va¡iax2 nla

657144 VariAx 2 Bone Screw. T10, Full Th read. 2.7mm / L44mm

VariAx 2 Bone Screw. T10. Full Thread, 2.7mm lL44mm


657144S

657146

B ilb cE0l23 13.01.2015 Variax2 nla

2 Bone Screw T Full Th 2.7mm I 8 ilb cE0123 30.04.2014 Yariax2 nla

6571465

657148

Va Screw TI Full Th 2.7mm lL46mm B ilb cE0123 '13.01 .2015 Yariax2 nla

VariAx 2 Bone T1 Full Th 2.7mm lL48mm (t ilb cE0123 30.o4.2014 Variax2 nla

657148S VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL48mm Õ ilb cE0123 13.01.2015 Variax2 nla

6571 50 VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL50mm B ilb cE0123 30.04.2014 Variax2 nla

6571 50s VariAx 2 Bone Screw, T10, Full Thread, 2.7mm / L50mm tt ilb cE0123 13.01.2015 Variax2 nla

a94qqq97199s

6571 60

VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL55mm Õ ilb c80123 30.04.2014 Variax2 nla

VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL55mm B ilb cE0123 13.01 .2015 Variax2 nla

VariAx 2 Bone Screw, T10, Full Thread, 2.7mm / L60mm I ilb cE0123 30.04.2014 Variax2 n/a

657160S 2 Bone Screw T1 Full Thread 2.7mm I I Ib c80123 13.01.2015 Variax 2 nla

6571 65 VariAx Screw T1 Full Th 2.7mm lL65mm I ilb cE0123 30.04.2014 Variax2 nla

6571 65S VariAx 2 Bone T1 Full Th 2.7mm lL65mm 8 ilb c80123 13.01 .2015 Yariax2 nla


657'f 70S VariAx 2 Bone Screw, T10, Full Thread, 2.7mm lL70mm I ilb c80123 13.01.2015 Variax2 nla

657308 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / LBmm tt ilb cE0123 30.04.2014 Variax 2 nla

657308S

65731 0

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / LBmm Õ ilb cE0123 13.01 .2015 Yariax2 nla

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / Ll0mm I ilb cE0r23 30.04.2014 Variax2 nla

65731 0S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L1Omm õ ilb cE0123 13.01 .2015 Variax2 nla

65731?.

6573'12S





B ilb cE0123 30.04.2014 Yariax2 nla

ilb cE0123 1 3.01 .2015 Variax2 nla

657314 ilb c80123 30.04.2014 Variax2 nla

6573145

65731 6

65731 65

IB

ilb cE0123 13.01 .2015 Va¡iax 2 nla

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L16mm ilb cE0r23 30.04.2014 Varia><2 nla



B ilb c80123 13.01.2015 Variax2 nla

65731 I ö ilb cE0123 30.04.2014 Va¡iax 2 nla

Form Templale DQF 01-006 Revision: 1.0 PRINTED COPIES FOR REFÊRENCE ONLY Pâge 15 of 25


VERSION: 4 EFFECTIVE DATE: Date of EcN Release

SYSTEM: VariAx 2

65731 8S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L18mm

RECORD REVIS¡ON" 17

I ilb cE0123 13.01 .2015 Variax 2 nla


657320S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L20mm I ilb c80123 13.01.2015 Yaria><2 nla

657322 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L22mm ö Ib cE0123 30.04.2014 Variax2 nla

6573225 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L22mm I ilb cE0123 13.01 .2015 Yariax2 nla

657324 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L24mm B ilb cE0123 30.04.2014 Varia><2 nla

657324S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm i L24mm I ilb cE0l23 13.01.2015 Varia;,<2 nla

657326 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L26mm I ilb cE0123 30.04.2014 Variax 2 nla

657326S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L26mm o ilb cE0123 13.01.2015 Yariø<2 nla

657328 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L28mm I ilb cE0123 30.04.2014 Yariax2 nla

657328S

657330

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L28mm I ilb cE0123 13.01.2015 Yariax2 nla

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L30mm I ilb cE9123 30.04.2014 Variax 2 nla

657330S

657332

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L30mm I ilb

ilb

cE0123 13.01 .2015 Ya¡iæ<2 nla

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L32mm B cE01 23 30.o4.2014 Variax2 nla

657332S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L32mm 8 ilb cE0123 r 3.01.2015 Variax 2 nla

657334 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L34mm Õ ilb cE0123 30.04.2014 Ya¡iax2 nla

657334S

657336

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm i L34mm B ilb cE0123 13.01 .2015 Variax2 nla

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm i L36mm 8 ilb cE0123 30.04.2014 Yariæ<2 nla

b5 ¡r JJOÞ VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L36mm 8 ilb cE0123 13.01 .20r 5 Variax2 nla

657338 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L3Bmm ö ilb cE0123 30.04.2014 Yariax 2 nla

657338S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L38mm I ilb cE0123 13.01.2015 Yariax2 nla


657340s VariAx 2 Locking Screw, T10, Full Thread, 3.5mm i L40mm I ilb cE0123 13.01 .20r s Variax2 nla


657342S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L42mm Õ ilb c80123 13.01 .2015 Yariax2 nla

657344 VariAx 2 Locking Screw, Tl0, Full Thread, 3.5mm / L44mm (t ilb c80123 30.04.2014 Variax2 nla

657344S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L44mm I ilb cE0123 13.01.2015 Yariax2 nla

657346 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L46mm I ilb c80123 30.04.2014 Variax2 nla

657346S

657348

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L46mm I ilb cE0123 13.01.2015 Variax2 nla

VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L48mm I ilb cE0123 30.04.2014 Variax2 nla

657348S VariAx 2 Locking Screw, T'10, Full Thread, 3.5mm / L48mm I ilb c80123 13.01.2015 Yariax2 nla

657350 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm i L50mm I ilb cE0't23 30.04.2014 Variax2 nla

657350S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L50mm I ilb cE0l23 13.01 .2015 Variax2 nla


657355S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm i L55mm I ilb cE0123 13.01.2015 Yariax2 nla

657360 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm i L60mm I ilb cE0l23 30.04.2014 Variax 2 nla

657360S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L60mm I ilb cE0123 13.01 .2015 Variax2 nla


657365S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm i L65mm 8 ilb c80123 13.01 .2015 Variax2 nla

657370 VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L70mm I ilb cE0123 30.04.2014 Variax 2 nla

657370S VariAx 2 Locking Screw, T10, Full Thread, 3.5mm / L70mm Õ ilb cE0123 13.01.2015 Variax2 nla

657408 VariAx 2 Bone Screw. T10, Full Thread, 3.5mm / LSmm I ilb cE0123 30.04.2014 Variax2 nla

657408S

657410

VariAx 2 Bone Screw. Tl0, Full Thread, 3.5mm / LSmm I ilb cE01 23 1 3.01 .2015 Variax2 nla

2 Bo ne Screw T1 Full Thread, 3.5m LI

2 Bone Screw T1 Full Thread 3 I

I ilb c|o123 30.04.2014 Yariax2 nla

65741 0s I ilb cE0123 13.01 .2015 Yariax2 nla

657412 2 Bone Screw T1 Full Thread 3.5mm L12mm I ilb cE01 23 30.04.2014 Variax2 nla

6574125 2 Bone Screw T1 Full Thread 3. L12mm I ilb cE0l 23 13.01.2015 Variax2 nla

657414 VariAx 2 Screw F¡,rll Thread 3,5mm / L14mm I ilb cEo123 30.04.2014 Variax2 nla

nla6574145 VariAx 2 Screw T1 3.5mm / mFull Thread I ilb cE0123 I 3.01 .2015 Variax2

Form Template DQF 01-006 Revìsion: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page 16 of 25

Trauma & Extremities Form stnyl<en"TITLE: DECLARATION OF CONFORMITY

VERSION: 4 EFFECTIVE DATE Date of EGN Release


657416 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm i Ll6mm I ltb cE0123 30.04.2014 Va¡iax2 nla

65741 65 VariAx 2 Bone Screw, Tl0, Full Thread, 3.5mm / L16mm I ilb cE0123 13.01.2015 Varidx2 nla

657418 VariAx 2 Bone Screw. T10, Full Thread, 3.5mm i Ll8mm I ilb cE0123 30.04.2014 Variax2 nla

65741 8S VariAx 2 Bone Screw. T10. Full Thread. 3.5mm / L18mm I ilb cE0123 13.01 .2015 Variax2 nla

657420 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L20mm B ilb cE0123 30.04.2014 Yariax2 nla

657420s VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L20mm I ilb cE0123 13.01.2015 Variax2 nla

657422

6574225

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L22mm (t ltb cE0123 30.04.2014 Variax2 nla

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L22mm 8 ilb cE0123 I 3.01 .2015 Variax2 nla

657424

6574245

VariAx 2 Bone Screw. T10, Full Thread, 3.5mm / L24mm 8 ilb cE0123 30.04.2014 Variax2 nla

VariAx 2 Bone Screw. T10. Full Thread, 3.5mm / L24mm I ilb cE0123 'l 3.01 .20r 5 Va¡iax2 nla

657426

657426S

VariAx 2 Bone Screw, T10, FullThread, 3.5mm / L26mm I ilb cE0l23 30.04.2014 Variax2 nla

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L26mm I ilb cE01 23 1 3.01 .2015 Variax2 nla

657428

657428S

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L28mm I ilb cE01 23 30.04.2014 Variax2 nla

VariAx 2 Bone Screw. T10, Full Thread, 3.5mm / L28mm Õ ilb cE0123 13.01.2015 Variax2 nla

657430 VariAx 2 Bone Screw. T10, Full Thread, 3.5mm / L30mm 8 ilb cEo123 30.04.2014 Variax2 nla

657430S VariAx 2 Bone Screw, T10, FullThread, 3.5mm / L30mm I ilb cE0123 13.01.2015 Yariax2 nla

657432 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L32mm I ilb cE0123 30.04.2014 Yariax2 nla

657432S VariAx 2 Bone Screw, Tl0, Full Thread, 3.5mm / L32mm I ilb cE0123 13.01.2015 Variax2 nla

657434

657434S

VariAx 2 Bone Screw. T10, Full Thread, 3.5mm / L34mm I ilb cE0123 30.04.2014 Variax2 nla

VariAx 2 Bone Screw. T10. FullThread, 3.5mm / L34mm I ilb cE01 23 13.01.2015 Yariax2 nla

657436 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L36mm 8 ilb cE9123 30.04.2014 Variax2 nla

657436S VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L36mm B Ib cE0'123 1 3.01 .2015 Variax 2 nla

657438 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L38mm tt ilb c80123 30.04.2014 Variax2 nla

657438S VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L38mm I ilb cE0123 13.01.2015 Variax2 nla

657440 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm i L40mm Õ Ib c80123 30.04.2014 Variax2 nla

657440s VariAx 2 Bone Screw, T10, Full read. 3.5mm / L40mm

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L42mm


657442 -

6574425

ö ilb cE0123 30.04.2014 Yariax2 nla

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L42mm 8 ilb cE0123 13.01.2015 Va¡iax2 nla

657444 VariAx 2 Bone Screw, T10. Full Thread, 3.5mm / L44mm I ilb cE0123 30.04.2014 Variax2 nla

6574445 VariAx 2 Bone Screw. T10. Full Thread, 3.5mm / L44mm I ltb cE0123 1 3.0't .201 5 Variax2 nla

657446 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L46mm B ilb cEol23 30.04.2014 Variax 2 nla

657446S VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L46mm I ilb cE0123 13.01.2015 Va¡iax2 nla

657448 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L48mm I ilb cEo123 30.04.2014 Yariax2 nla

657448S VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L48mm I Ib cE0123 13.01.2015 Variax 2 nla

657450 VariAx 2 Bone Screw. T10. Full Thread, 3.5mm / L50mm I ilb c80123 30.04.2014 Variax2 nla

657450S VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L50mm 8 ilb cE01 23 13.01.2015 Yariax2 nla

657455 VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L55mm 8 ilb cE0123 30.04.2014 Variax2 nla

657455S

657460

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L55mm I ilb cE0123 13.01.2015 Variax2 nla

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L60mm B ilb cE0123 30.04.2014 Variax2 nla

657460S VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L60mm 8 ilb cE0123 13.01.2015 Variax2 nla

VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L65mm õ ilb c80123 30.04.2014 Variax2 nla

657 VariAx2 Bone Screw. Tl0, Full Thread, 3.5mm / L65mm B ilb c80123 13.01 .2015 Va¡iax2 nla

657470 2 Bone Screw T1 Full 3.5mm / L70mm I ilb cE0123 30.04.2014 Variax2 nla

657470S VariAx 2 Bone Screw, T10, Full Thread, 3.5mm / L70mm B ilb c80123

CE

13.01.2015

30.06.2015

Yariax2

VariAx 2

nla

940210 Upper Core Tray 1 nla

940211 Upper Add-on Tray, Elbow 1 CE 30.06.2015 VariAx 2 nla

940212 Upper Add-on Tray, Clavicle I CE 30.06.2015 VariAx 2 nla

940220 Upper Adcl-on Tray, Small Fragment 1 CE 30.06.2015 VariAx 2 nla

s40221 Upper Add-on Tray, Wrist 1 CE 30.06.2015 VariAx 2 nla

Form Template DQF 01-006 Revision: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page 17 ol 25

Trauma & Extremities Form stnyken'TITLE DECLARATION OF CONFORM ITY



1 500-0007 Lower Tray 1 Level 1 I CE 30.06.20't5 VariAx 2 nla

940232 Screw Rack Locking Screws 1 I CE 30.06.2015 VariAx 2 nla

940233 Screw Rack Non-Locking Screws 1 I CE 30.06.2015 VariAx 2 nla

940234 Screw Rack 1 CE 30.06.2015 VariAx 2 nla

940235 Screw Rack 1 CE 30.06.2015 VariAx 2 nla

940236

940250

Screw Rack Asnis lll 1 CE 30.06.2015 VariAx 2 nla

Reduction lnstrument lnsert 1 1 CE 30.06.2015 VariAx 2 nla

940251 Reduction lnstrument lnsert 2 1 CE 30.06.2015 VariAx 2 nla

940252

940253

Reduction lnstrument lnsert 3 1 CE 30.06.2015 VariAx 2 nla

T8 Add-on lnstrument lnsert 1 CE 30.06.2015 VariAx 2 nla

940254 Narrow Compression Plate lnsert I CE 30.06.2015 Variþx2 nla

940255 Broad Compression Plate lnsert 1 CE 30.06.2015 VariAx 2 nla

940256 l/3 Tubular Plate lnsert I CE 30.06.2015 VariAx 2 nla

940257 Distal Lateral Fibula Plate lnsert 1 CE 30.06.2015 VariAx 2 nla

940258 Lateral Elbow Plate lnsert, LEFT 1 CE 30.06.2015 VariAx 2 nla

940259 Lateral Elbow Plate lnsert, RIGHT 1 CE 30.06.2015 VariAx 2 nla

940274 Posterior Medial Elbow Plate lnsert 1 CE 30.06.2015 VariAx 2 nla

940276 Posterior Lat. Elbow Plate lnsert, LEFT 1 CE 30.06.2015 VariAx 2 nla

940262 Posterior Lat. Elbow Plate lnsert, RIGHT 1 CE 30.06.2015 VariAx 2 nla

940263 Olecranon Plate lnsert 1 CE 30.06.2015 VariAx 2 nla

940264 Medial Elbow Plate lnsert 1 CE 30.06.2015 VariAx 2 nla

940265 Sup Decr Curve Clav Plate lnsert, LEFT 1 CE 30.06.2015 VariAx 2 nla

940266 Sup Decr Curve Clav Plate lnsert, RIGHT 1 CE 30.06.2015 VariAx 2 nla

940267 Superior Lateral Clavicle Plate lnsert 1 I CE 30.06.2015 VariAx 2 nla

940268 Sup lncr Curve Clavicle Plate lnsert 1 I CE 30.06.2015 VariAx 2 nla

940269

940270

Clavicle Hook Trial lnsert 1 I CE 30.06.2015 VariAx 2 nla

Frag Spec Distal Radius Plate lnsert 1 I CE 30.06.2015 VariAx 2 nla

940271 Dorsal Distal Radius Plate lnsert 1 I CE 30.06.2015 VariAx 2 nla

940272 Distal Radius Aiming Block lnsert 1 I CE 30.06.2015 Vari{x2 nla

940273 4.0mm Asnis lll lnstrument lnsert 1 I CE 30.06.2015 VariAx 2 nla

940275 Half Height Generic lnsert 1 I CE 30.06.2015 VariAx 2 nla

s40330 Core Tray Top Layer Clip I I CE 30.06.2015 VariAx 2 nla

940331 Core Tray T10 Screw Drawer CliP 1 CE 30.06.2015 VariAx 2 nla

940332 Core Tray T8 lnstr & Screw Drawer Clip 1 Utr 30.06.2015 VariAx 2 nla

940333 Core Tray Reduction lnstr Drawer Clip 1 CE 30.06.2015 VariAx 2 nla

940334

940335

Elbow Add-on, Top Layer Clip 1 CE 30.06.2015 VariAx 2 nla

Elbow Add-on, Lateral Plate Drawer Clip 1 CE 30.06.2015 VariAx 2 nla

940336

940337

Elbow Add-on, Olec/Med Plate Drawer Clip 1 CE 30.06.2015 VariAx 2 nla

Clavicle Add-on, Top Layer Clip 1 CE 30.06.2015 VariAx 2 nla

940338 Clavicle Add-on, Plate Drawer Clip 1 CE 30.06.2015 VariAx 2 nla

940339

940340

Clavicle Add-on, Hook Trial Drawer Clip 1 CE 30.06.2015 VariAx 2 nla

Small Frag Add-on, Top Layer Clip 1 CE 30.06.2015 VariAx 2 nla

940341 Small Frag Add-on, Plate Drawer Clip 1 CE 30.06.2015 VariAx 2 nla

940342 Small Frag Add-on, Asnis lll Drawer Clip

Wrist Add-on, Top Layer Clip

1 CE 30.06.2015 VariAx 2 nla

940343 1 Utr 30.06.2015 VariAx 2 nla

940344 Wrist Add-on, Plate Drawer Clip 1 CE 30.06.2015 VariAx 2 nla

940345 Black Blank Clip 1 Utr, 30.06.2015 VariAx 2 nla

940346 Grey Blank Clip 1 CE 30,06.2015 VariAx 2 nla

9401 60 Upper Tray, F&A I CE 30.06.2015 VariAx 2 nla


Trauma & Extremities Form stnyker'TITLE: DECLARATION OF CONFORMITY

VERSION: 4 EFFECTIVE DATE: Date of EcN Release

SYSTEMI VariAx 2 RECORD REVISION: 17

9401 61

940162

Screw Rack - Locking Screws 1 I CE 30.06.2015 VariAx 2 nla

Screw Rack - Non-Locking Screws 1 I CE 30.06.2015 VariAx 2 nla

940163 Screw Rack 1 I CE 30.06.2015 VariAx 2 nla

940164 Screw Rack I I CE 30.06.2015 YariAx2 nla

9401 65 lnsert - Reduction lnstruments 1, F&A 1 I CE 30.06.2015 VariAx 2 nla

9401 66 lnsert - Reduction lnstruments 2, F&A 1 I CE 30.06.2015 VariAx 2 nla

940167 Module - NCM Plates 1 I CE 30.06.2015 VariAx 2 nla

940168 Module - TN, NC Plates 1 I CE 30.06.2015 VariAx 2 nla

940169 Module - LCL Plates 1 CE 30.06.2015 VarlAx 2 nla

940170 Module - Cuboid, Navicular, Talus Plates 1 CE 30.06.2015 VariAx 2 nla

940171 Module - Curved, Straight Plates 1 CE 30.06.2015 VariAx 2 nla

940172 Module - 3D, T, Oblique T, L Plates 1 CE 30.06.2015 VariAx 2 nla

940173 Module - H, Rectangular Plates 1 CE 30.06.2015 VariAx 2 nla

940174 Module - Calcaneal Plates 1 CE 30.06.2015 VariAx 2 nla

940175 Labeling Clip 1 CE 30.06.2015 VariAx 2 nla

940176 Screw Rack Lid 1 CE 30.06.2015 Vari{x2 nla

940177 Module Lid 1 CE 30.06.2015 VariAx 2 nla

940178

940179

Labeling Clip 1 CE 30.06.2015 VariAx 2 nla

Labeling Clip 1 CE 30.06.2015 VariAx 2 nla

1 500-0002 Tray Lid 'l CE 30.06.2015 VariAx 2 nla

I 500-0006 Tray - Lower Part 1 CE 30.06.2015 VariAx 2 nla

1 500-0005 Drawer - half size

Clip

Bending Template For One-Third Tubular Plate 5 Hole

Bending Template For One-Third Tubular Plate 10 Hole

1 CE 30.06.2015 VariAx 2 nla

940460 I CE 30.06.2015 VariAx 2 nla

705275 1 CE 12.08.2015 VariAx 2 nla

705280 1 CE 12.08.2015 VariAx 2 nla

705286 Bending Template For One-Third Tubular Plale 16 Hole 1 CE 12.08.2015 VariAx 2 nla

981215 X-RayTemplate X-Ray Template One-Third Tubular Plate 1 I CE 12.08.2015 VariAx 2 nla

626672 One-Third Tubular Plate 2 Hole / L23mm I ilb c80123 12.08.2015 VariAx 2 nla

626673 One-Third Tubular Plate 3 Hole / L35mm I ilb cE0123 12.08.2015 VariAx 2 nla

626674 One-Third Tubular Plate 4 Hole lL47mm I ilb cE0123 12.08.2015 VariAx 2 nla

626675 One-Third Tubular Plate 5 Hole / L59mm I ilb c80123 12.08.2015 VariAx 2 nla

626676

626677

One-Third Tubular Plate 6 Hole / L7'1mm I ilb cE0123 12.08.2015 VariAx 2 nla

One-Third Tubular Plate 7 Hole / L83mm Õ ilb cE0r23 12.08.201s VariAx 2 nla

626678

626675

626680

One-Third Tubular Plate B Hole / L95mm I ilb cE0123 12.08.2015 VariAx 2 nla

One-Third Tubular Plate 9 Hole / L107mm I ilb cE0123 12.08.2015 VariAx 2 nla

One-Third Tubular Plate 10 Hole / L'l19mm I ilb cE0123 12.08.2015 VariAx 2 nla

626682

626684

One-Third Tubular Plate 12 Hole / L143mm B ilb cE0l23 12.08.2015 VariAx 2 nla

One-Third Tubular Plate 14 Hole / L167mm



8 ilb cE0123 12.08.2015 VariAx 2 n/a

bzbbõb

626672S

0 ilb cE0123 12.08.2015 VariAx 2 nla

B ilb cE0123 12.08.2015 VariAx 2 nla

626673S One-Third Tubular Plate 3 Hole / L35mm

One-Thìrd Tubular Plate 4 Hole lL47mm

I ilb cE0123 12.O8.2015 VariAx 2 nla

626674S tt ilb cE0123 1208.2015 VariAx 2 nla

6266755 One-Third Tubular Plate 5 Hole / L59mm I ilb cE0r23 12.08.2015 VariAx 2 nla



I ilb cE0123 12.08.2015 VariAx 2 nla

626677S I ilb cE0123 12.08.2015 VariAx 2 nla

626678S One-Third Tubular Plate 8 Hole / L95mm 8 ilb cE0123 12.O8.2015 VariAx 2 nla

626679S One-Third Tubular Plate 9 Hole / L107mm I ilb c80123 12.08.2015 YariAx2 nla

626680S One-Third Tubular Plate 10 Hole / L1 l9mm I ilb cE0l23 12.08.2015 VariAx 2

VariAx 2

nla

nla626682S One-Third Tubular Plate 12 Hole / L143mm I Ib cE0123 12.08.2015


Trauma & Extremities Form stryl<en'TITLE DECLARATION OF CONFORMITY


SYSTEM: VariAx 2 RECORD REVISION 17



I ilb cE0123 12.08.2015 VariAx 2 nla

626686S I ilb cE0123 12.08.2015 VariAx 2 nla

940090

940092

Wrist Fusion Tray 1 I CE 22.09.2015 VariAx 2 nla

Wrist Fusion lmplant&lnstrument lnsert 1 I CE 22.09.2015 VariAx 2 nla

940093

940094

Wrist Fusion Tray Labeling Clip I I CE 22.O9.2015 VariAx 2 nla

Wrist Fusion Screw Rack TB 1 I CE 22.09.2015 VariAx 2 nla

940095 Wrist Fusion Screw Rack T10 1 I CE 22.O9.2015 VariAx 2 n/a

940096 Wrist Fusion Drawer Labeling Clip 1 I CE 22.09.2015 VariAx 2 nla

705305 Wrist Fusion Plate Trial standard bend o I CE 22.09.2015 VariAx 2 nla

705306 Wrist Fusion Plate Trial short bend 6 I CE 22.09.2015 VariAx 2 nla

705307 Wrist Fusion Plate Trial straight b CE 22.O9.2015 VariAx 2 nla

629579 Wrist Fusion Plate standard bend 8 ilb c80123 22.09.2015 VariAx 2 nla

629589 Wrist Fusion Plate short bend ilb cE0123 22.05.2015 VariAx 2 nla

629590 Wrist Fusion Plate straight I ilb cE0123 22.09.2015 VariAx 2 nla

629579S Wrist Fusion Plate standard bend 8 ilb c80123 22.09.2015 VariAx 2 nla

629589S Wrist Fusion Plate short bend (t ilb cE0l23 22.09.2015 VariAx 2 nla

629590S

703901

Wrist Fusion Plate straight B ilb cE0123 22.09.2015 VariAx 2 nla

Drill Bit, AO, scaled, Ø2.6mmx220mm b lla cE0123 31.12.2015 Variax2 nla

703901 S Drill Bit, AO, scaled, Ø2.6mm x220mm 6 lla c80123 31.12.2015 Yariax2 nla

703902 Drill Guide K-Wire/ Fixed Angle T8; Ø1.1mm, Ø2.0mm

Wire Bending lron, Ø1.0 - 2.0mm

b CE 31.12.2015 Variax2 nla

705299

940213

b CE 31.12.2015 Variax 2 nla

Upper Tray Dedicated Wrist 1 CE 01.02.2016 VariAx 2 nla

940215

940216

Upper Tray, Gener¡c 1 CE 01.02.2016 VariAx 2 nla

Upper Tray, Small Fragment 1 CE 01.02.2016 VariAx2 nla

940277 Volar Distal Radius Plate lnserl, Right 1 CE 01.02.2016 VariAx 2 nla

940278 Volar Distal Radius Plate lnsert, LEFT I CE 01.02.2016 VariAx 2 nla

940279 Distal Radius Plate lnsert, LÉFT 1 CE 01.02.2016 VariAx 2 nla

940280 XXL Distal Radius Plate lnsert, Right 1 CE 01 .02.2016 VariAx 2 nla

940281 Fibula Straight Plate lnsert 1 I CE 01.02.2016 VariAx 2 nla

940347 Wrist Tray Top Layer Clip 1 I CE 01.02.2016 VariAx 2 nla

940348 Wrist Tray Screw Drawer Clip 1 I CE 01.02.2016 VariAx 2 nla

940349 Wrist Tray Plate Drawer Clip 1 I CE 01.02.2016 VariAx 2 nla

940350 Wrist T Reduction lnstrument Clip

Small Fragment Tray Top Layer Clip

1 I CE 01.02.2016 VariAx 2 nla

940351

940352

1 I CE 01.02.2016 VariAx 2 nla

Small Fragment Tray Screw Drawer Clip 1 I CE 01.02.2016 VariAx 2 nla

940353 Small Fragment Tray Plate Drawer Clip 1 I CE 01.02.2016 VariAx 2 n/a

940354

940359

940360

Small Fragment Tray Reduction lnstr Clip 1 CE 01.02.2016 VariAx 2 nla

Foot Add-on Tray Top Layer Clip 1 CE 01.02.2016 VariAx 2 nla

Foot Add-on Tray Plate Drawer Clip 1 CE 01 .02.2016 VariAx 2 nla

940361 1/1 Size Silicone Mat 1 CE 01.02.2016 VariAx 2 nla

940362 112 Size Silicone Mat I CE 01.02.2016 VariAx 2 nla

940461 Labeling Clip - Reduction & Reamer I CE 06.04.2016 Anchorage 2 CP nla

940462 Labeling Clip - CP Drawer 1 CE 06.04.2016 Anchorage 2 CP nla

940463 Module - MTP/Universal CP

Module - Midfoot CP

1 CE 06.04.2016 Anchorage 2 CP nla

940464 1 CE 06.04.2016 Anchorage 2 CP nla

940465 Module - Lapidus CP, Left I CE 06.04.20'16 Anchorage 2 CP nla

940466 Module - Lapidus CP, Right 1 Utr 06.04.2016 Anchorage 2 CP nla

940467

940468

lnsert - Reduction lnstruments 3 1 CE 06.04.2016 Anchorage 2 CP

Anchorage 2 CP

nla

nlalnsert - Reamer 1 CE 06.04.2016

Form Template DQF 01-006 Revision: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page20 of 25



SYSTEM:

CP Screw ø3.6

VariAx 2 RECORD REVISION' 17

940469 Screw Rack CP 1 I CE 06.04.2016 Anchorage 2 CP nla

940470 lnsert - CP lnstruments 1 I CE 06.04.2016 Anchorage 2 CP nla

940471 Screw Rack Lid CP 1 I CE 06.04.2016 Anchorage 2 CP nla

626890 Midfoot CP Plate ö ilb cE0123 06.04.2016 Anchorage 2 CP nla

626891

626892

MTP CP Plate I ilb cE0123 06.04.2016 Anchorage 2 CP nla

MTP CP Plate B ilb cE9123 06.04.2016 Anchorage 2 CP nla

626893 Lapidus CP Plate o ilb cE0123 06.04.2016 Anchorage 2 CP nla

626894 Lapidus CP Plate 8 ilb cE0123 06.04.2016 Anchorage 2 CP nla

626895 Universal CP Plate 8 ilb cE0l23 06.04.2016 Anchorage 2 CP nla

626898 Midfoot CP Plate I ilb cE0123 06.04.2016 Anchorage 2 CP nla

626900 Lapidus CP Plate 8 ilb cE0l23 06.04.20'16 Anchorage 2 CP nla

626901 Lapidus CP Plate I Ib cE0123 06.04.2016 Anchorage 2 CP nla

626902 Lapidus CP Plate I ilb cE0123 06.04.20r 6 Anchorage 2 CP nla

626903 Lapidus CP Plate I ilb cE0123 06.04.2016 Anchorage 2 CP nla

626890S Midfoot CP Plate I ilb c80123 06.04.2016 Anchorage 2 CP nla

626891 S MTP CP Plate Õ ilb c80123 06.04.2016 Anchorage 2 CP nla

626892S

626893S

626894S

626895S

MTP CP Plate

Lapidus CP Plate

B ilb cE0123 06.04.2016 Anchorage 2 CP nla

8 ilb cE0123 06.04.2016 Anchorage 2 CP nla

Lapidus CP Plate I ilb cE0123 06.04.2016 Anchorage 2 CP nla

Universal CP Plate 8 ilb cE0123 06.04.2016 Anchorage 2 CP nla

6268985

626900S

Midfoot CP Plate 8 ilb cE0123 06.04.2016 Anchorage 2 CP nla

Lapidus CP Plate I ilb cE0123 06.04.2016 Anchorage 2 CP nla

626901 S Lapidus CP Plate I ilb cE0123 06.04.2016 Anchorage 2 CP nla

626902S Lapidus CP Plate B ilb cE0123 06.04.2016 Anchorage 2 CP nla

626903S Lapidus CP Plate 8 Ib cE0123 06.04.2016 Anchorage 2 CP nla

626820 CP Screw ø4.1 I ilb cEo123 06.04.2016 Anchorage 2 CP nla

626822 CP Screw ø4.'1 8 lrb cE.l123 06.04.2016 Anchorage 2 CP nla

626824 CP Screw ø4.1 tt ilb cE0123 06.04.2016 Anchorage 2 CP nla

626826 CP Screw ø4.1 I ilb cE0123 06.04.2016 Anchorage 2 CP nla


626830

626832

CP Screw ø4.1 (t trb cE0123 06.04.2016 Anchorage 2 CP nla

CP Screw ø4.1 8 ilb cEo123 06.04.2016 Anchorage 2 CP nla

626834 CP Screw ø4.1 ö ilb cE0123 06.04.2016 Anchorage 2 CP nla

626836 CP Screw ø4.1 I ilb cE01 23 06.04.2016 Anchorage 2 CP nla

626838 CP Screw ø4.1 I ilb c80123 06.04.2016 Anchorage 2 CP nla

626840 CP Screw ø4.1 8 ilb cE0123 06.04.2016 Anchorage 2 CP nla








626865 CP Screw ø4.1

CP Screw ø4.1

a ilb cE0l23 06.04.2016 Anchorage 2 CP nla

626870 I Ib cE1123 06.04.2016 Anchorage 2 CP nla

626920 CP Screw ø3.6 ö ilb cE0123 06.04.2016 Anchorage 2 CP nla

626922

626924

CP Screw ø3.6 I ilb c80123 06.04.2016 Anchorage 2 CP nla

CP Screw ø3.6 8 ilb cF.1123 06.04.2016 Anchorage 2 CP

Anchorage 2 CP

nla

nla626926 I ilb c80123 06.04.2016

Form Template DQF 01-006 Revision: 1.0 PRINTED COPIÊS FOR RÊFERENCE ONLY Page 21 of 25


VERSION 4 EFFECTIVE DATE: Date of ECN Release




626532

626934

CP Screw ø3.6 I ilb cEo123 06.04.2016 Anchorage 2 CP nla

CP Screw ø3.6 I ltb cE0123 06.04.2016 Anchorage 2 CP nla


626938

626940

CP Screw ø3.6 B ilb cE0123 06.04.20't6 Anchorage 2 CP nla

CP Screw ø3.6

CP Screw ø3.6

I ilb cE0l23 06.04.2016 Anchorage 2 CP nla

626942 I ilb c80123 06.04.2016 Anchorage 2 CP nla


626820S CP Screw ø4.'1 I ilb c80123 06.04.2016 Anchorage 2 CP nla


626824S CP Screw ø4.1 I ilb cE0123 06.04.2016 Anchorage 2 CP nla

626826S CP Screw ø4.1 B ilb cE0123 06.04.2016 Anchorage 2 CP nla

626828S CP Screw ø4.1 I Ib c80123 06.04.2016 Anchorage 2 CP nla

626830S CP Screw ø4.1

CP Screw ø4.1

CP Screw ø4.1

8 ilb cE0123 06.04.2016 Anchorage 2 CP nla

626832S

626834t

I ilb cE0123 06.04.2016 Anchorage 2 CP nla

I lrb cE0123 06.04.2016 Anchorage 2 CP nla

626836S

626838S

626840S

CP Screw ø4.1 I ilb cE0123 06.04.2016 Anchorage 2 CP nla



626842S CP Screw ø4.1 I ilb cEo123 06.04.2016 Anchorage 2 CP nla

626844S CP Screw ø4.1 I ilb cE0l23 06.04.2016 Anchorage 2 CP nla




626855S CP Screw ø4.1 B ilb cE0123 06.04.2016 Anchorage 2 CP nla


626865S CP Screw ø4.1 I ilb c80123 06.04.2016 Anchorage 2 CP nla

626870S CP Screw ø4.1 8 ilb cE0'123 06.04.2016 Anchorage 2 CP nla

626920S CP Screw ø3.6 I ilb cE0l23 06.04.2016 Anchorage 2 CP nla



626926S CP Screw ø3.6 8 ilb cEo123 06.04.2016 Anchorage 2 CP nla

626928S CP Screw ø3.6 I ilb c80123 06.04.2016 Anchorage 2 CP nla

626930S CP Screw ø3.6 8 ltb cE0123 06.04.2016 Anchorage 2 CP nla

626932S CP Screw ø3.6 I ilb cEo123 06.04.2016 Anchorage 2 CP nla

626934S

626936S

CP Screw ø3.6 I ilb cEo123 06.04.2016 Anchorage 2 CP nla

CP Screw ø3.6 B ilb cE0123 06.04.2016 Anchorage 2 CP nla




6269445 CP Screw ø3.6 I ilb cEo123 06.04.2016 Anchorage 2 CP nla

705171 CP Drill Guide o CE 06.04.2016 Anchorage 2 CP nla

705173 CP Drill Guide ô

lla

CE

cE0123

06.04.2016

06.04.2016

Anchorage 2 CP nla

705172 CP Reamer 6 Anchorage 2 CP nla

705176

705177

705178

CP Template, Midfoot o CE 06.04.2016 Anchorage 2 CP nla

CP Template, MTP 6 CE 06.04.2016 Anchorage 2 CP nla

CP Template, MTP 6 CE 06.04.2016 Anchorage 2 CP nla

705179 CP Template, Lapidus 6 CE 06.04.2016 Anchorage 2 CP nla

Form Template DQF 01-006 Revision: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page22 of 25

Trauma & Extremities Form stnyken'TITLE DECLARATION OF CONFORMITY


SYSTEM:

7051 80 CP Template, Lapidus

705182 CP Template, Unìversal

7051 83 CP Template, Midfoot

940237 Auxiliary Screw Rack, T10

VariAx 2 RECORD REVISION: 17

6 CE 06 04.2016 Anchorage 2 CP nla

f) CE 06.04.20'16 Anchorage 2 CP nla

^CE 06.04.2016 Anchorage 2 CP nla

1 CE 31.03.2017 VariaAx 2 nla

940363 Lid for Auxiliary Screw Rack, T10 1 CE 31.03.2017 VariaAx 2 nla

940283 Lid for Aiming block lnsert 1 CE 31 .03.2017 VariaAx 2 nla

705760 Wedge Trial 6 I CE 18.08.2017 VariaAx 2 nla

705761 Wedge Trial b I CE 18.08.2017 VariaAx2 nla

705762 Wedge Trial 6 I CE 18.08.2017 VariaAx 2 nla

705763

940472

Wedge Trial ¡ CE 18.08.2017 VariaAx 2 nla

lnsert - Wedge Trials 1 I CE 30.08.2017 VariaAx 2 nla

940473

940474

Module - Straight Plates 1 I CE 30.08.2017 VariaAx 2 nla

Module-SlimYPlates 1 I CE 30.08.2017 VariaAx 2 nla

940475

940476

Module-BroadYPlates 1 I CE 30.08.2017 VariaAx 2 nla

Labeling Clip - Plate Modules 2 1 CE 30.08.2017 VariaAx 2 nla

991 051 S

991 0525

VariAx 2 Xpress DR lmplant Kit narrow, extra-short, LEFT

54:2þ57365631 26563'1465631 665631 IbSbJzu65641 0

656412656414

Anatomical Volar DR Plate, narrow, extra-short left

Locking Screw, T8, full thread, 2.7mm,112-L2Qmm

Non-locking Screw, T8, full thread, 2.7mm,110-L14mm

I ilb cE 0123 04.05.2017 VariAx 2 nla

VariAx 2 Xpress DR lmplant Kit narrow, extra-short, RIGHT

54-2558365631 2

65631 4ocÞJ to65631 I656320

Anatomical Volar DR Plate, narrow, extra-short. rioht

I ilb cE 0123 04.05.2017 VariAx 2 nlaLocking Screw, T8, full thread, 2.7mm,L12-L2Omm

65641 0656412656414

Non-locking Screw, TB, full thread, 2.7mm,110-L14mm

991 053S

VariAx 2 DR lm Kit narrow, short, LEFT

54-25374Anatomical Volar DR Plate, narrow, short,left

65631 265631465631 665631 I656320

Õ ilb c80123 04.05.2017 VariAx 2 nlaLocking Screw, T8, full thread, 2.7mm,112-L20mm

65641 0656412656414

Non-locking Screw, TB, full thread, 2.7mm,11O-Ll4mm

991 054S

VariAx 2 Xpress DR lmplant Kit narrow, long, LEFT

54-25384Anatomical Volar DR Plate, narrow, shortriqht

Õ ilb cE 0123 04.05.2017 VariAx 2 nla

65631265631465631 665631 B

656320Locking Screw, T8, full thread, 2.7mm112-L20mm

6564'1065641?656414

Non-locking Screw, TB, full thread, 2.7mm,110-L14mm

Form Template DQF 01-006 Revision: 1.0 PRINTÉD COPIES FOR REFERENCE ONLY Pagê 23 of 25




VariAx 2 Xpress DR lmplant Kit narrow, long, LEFT

991 055ScE 0123 04.05.2017 VariAx 2ilb

cE 0123 04.05.2017 VariAx 2

nla8

RIGHT

ilb nlaBLocking Screw, TB, full thread, 2.7mm,112-L20mm

54-25375

54-25385

14

VariAx 2 Xpress DR lmplant Kit narrow, I

Anatomical Volar DR Plate, narrow, long,

65631

65641

Anatomical Volar DR Plate, narrow, long,left

Locking Screw, T8, full thread, 2.7mm,112-L20mm

Non-locking Screw, T8, full thread, 2.7mmL10-L14mm

65631 265631465631665631 I656320

65641 0656412 Non-locking Screw, T8, full thread, 2.7mm

110-L14mm

656412656414

65631465631665631 I656320

991 056S

VariAx 2 Xpress DR lmplant Kit intermedi extra-short, LEFT

Anatomical Volar DR Plate, intermediate,extra-short, left

Locking Screw, T8, full thread, 2.7mrî,L14-L22mm

54-25673

65631465631 665631 I656320656322

nlao ilb cE 0123 04.05.2017 VariAx 2


991 0575

65641265641465641 6

VariAx 2ilb cE 0123 04.05.2017

2-Ll6mm

nlaI

VariAx 2 Xpress DR lm lant Kit intermediate, extra-short, RIGHT

54-25683

Non-locking Screw, T8, full thread, 2.7mm,

Anatomical Volar DR Plate, intermht

Locking Screw, TB, full thread, 2.7mm,L1 m

65631465631 665631 I656320656322656412656414656416

991 05BS

VariAx 2ilb cE 0123 04.05.2017

s

nlaB

54-25674

VariAx 2 Xpress DR lmplant Kit intermediate, short, LEFT

Anatom¡cal Volar DR Plate, intermediate,

16

Locking Screw, T8, full thread, 2.7mmL14-L22mm


6563146563'r665631 I656320656322656412656414

991 0595

VariAx 2 Xpress DR lmplant K¡t intermediate, short, RIGHT

54-25684Anatomical Volar DR Plate, intermediate,short. riqht

nlailb cE 0123 04.05.2017 VariAx 2I991 060S65631465631 665631 B

Locking Screw, T8, full thread, 2.7mm,L14-l22mm

Form Template DQF 01-006 Revision: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page 24 o:l 25





991 061 S

VariAx 2 Xpress DR lmplant Kit intermediate, long, LEFT

54-25677Anatomical Volar DR Plate, intermediate,lonq. left

I Ib cE 0123 04.05.2017 VariAx 2 nla

65631465631 665631 I656320656322

Locking Screw, T8, full thread, 2.7mm,L14-L22mm

656412656414656416


991 062S

VariAx 2 Xpress DR lmplant Kit intermediate, long, RIGHT

54-25687Anatomical Volar DR Plate, intermediate,lonq. rioht

I Ib cE 0123 04.05.2017 VariAx 2 nla

65631465631665631 I656320656322

Locking Screw, T8, full thread, 2.7mmL14-L22rnm

65641265641465641 6


Form Template DQF 01 -006 Revision: 1.0 PRINTED COPIES FOR REFERENCE ONLY Page25 o:125

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