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TECHNICAL FILE - DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2

Revision: 2
Date Issued: 04/21/11
REF: SOP 2. I .2 TECHNICAL FILE PROCEDURE Page: I of3

Technical File - Declaration of Conformity

Teclu1ical File: EX-002

I
Biomet Orthopedics Biomet U.K. Limited
P.O. Box 587 Wate1ton Industrial Estate
56 East Bell Drive South Wales Bridgend
Warsaw, Indiana 4658 1 CF 3 1 3XA
USA United Kingdom
~800-348-95 00 ~4- l656-65522 1 ~ 44- 1656-645454

We hereby declare under our sole responsibility that the following products
meet the classification, requirements, relevant directive provisions, harmonized
standards, normative documents, registrations and ce1tifications referenced
below and within the technical file referenced above.

Extremity I Elbow I Implantable Devices

ExploR™ Modular Radial Head System

Patt number listi ng below

Class Ilb
Per Rule 8 of Annex IX of the Council Directive 93/42/EEC concerning
medical devices i.e. Med ical Device Directive~ MOD.

Council Directive 93/42/EEC and subsequent amendments concerning medical devices, i.e,
Medical Device Directive - MOD:
I Annex I Essential Re .uirements . .
i Annex II EC Declaration of Confonrnty Full QAS - (Sect10114 exce

Certificate No.
I CE 0246 1
FM 7 1264 CMDCAS Certificate
Notified Body: Notified Body No.:
BSI Product Services 0086
Maylands Avenue
Heme! Hempstead
Hertfordshire HP2 4sQ
United Kin

Dccluration of Conformity Prepared Date: Aug ust 30, ZOll

Ucvision: B
 I
TECHNICAL FILE - DECLARATION OF CONFORMITY Document Nu mber: INST. 2.1.2.2
Revision: 2
Date Issued: 04/2 1/l l
REF: SOP 2. I .2 TECHNICAL FILE PROCEDURE Page: 2 of3

-
[-- illifiifi'•r;,1Ji11xuwoo~~ Jt '"""'"ilUllllJH
- - cB~IOOCit.'rfh,
11-2 100 11 ExploR™ Implant Head - 8 x l 8mm 35966
11 -2 100 12 ExploR™ lmplanl Head - I 0 x I8111111 35966
ll -2 10013 Exri loRrM l111plant I lead - 12 x 18111 111 35966
ll-210014 ExploRTM [mplant I lead- 14 x l8mm 35966
l 1-210015 ExploRTM Im plant I lead - 16 x 18mm 35966
11 -210016 ExploRTM Implant Head - 18 x 18mm 35966
11-2 10017 ExploR™ lmplant Head - 20 x 18mm 35966
11-210021 ExploRrn J.mplant Head - 8 x 20mm 35966
11-210022 ExploRTMImplant Head - I 0 x 20mm 35966
11-2 10023 ExploRTM Implant Head - 12 x 20mm 35966
11 -2 10024 ExoloRTMImp lant Head - 14 x 20111111 35966
11-210025 ExploRTM Implant I lead - 16 x 20mm 35966
11-2 10026 Exo loRTMImplant I lead - 18 x 20nun 35966
11-2 10027 Exp loRTM Implant Head - 20 x 20mm 35966
11-2 10031 Exp loR™ Implant Head - I 0 x 22mm 35966
11-210032 ExploRTM Implant Head - 12 x 22111111 35966
11-2 10033 Exp loR™ Implmit Head - 14 x 22111111 35966
11 -2 10034 ExploRTM Implant I read - 16 x 22mm 35966
11 -2 10035 ExploRTM Implant Head - 18 x 22mm 35966
11 -2 10036 ExploRTM Implant Head - 20 x 22111111 35966
11-210041 ExploRTM Imp lant Head - 10 x 24mm 35966
11-2 10042 ExploRTM Implant Head - 12 x 24mm 35966
11-210043 l::xploRTM Implant Head - 14 x 24mm 35966
11-2 10044 ExploRTM Implant Head - 16 x 24m111 35966
11-210045 ExploR™ Implant Head - 18 x 24mm 35966
11 -210060 ExploR™ Implant Stem with Screw - 5mm x 22111111 33701
11-2 1006 1 EXJ)loRTM Implant Stem with Screw - 6mm x 24nrn1 33701
11-2 10062 ExploRTM Implant Stem with Screw - 7mrn x 26mm 3370 1
11 -2 10063 ExploR™ Implant Stem with Screw - 8mm x 28mm 33701
11 -2 10064 ExploR™ Implant Stem with Screw - 9mm x 30mm 33701
11-210065 ExoloRTM Implant Stem with Screw - lOmm x 32111111 33701
11-210099 ExploRTM Implant Lockirig Screw 32854
End of product list

GMDN Code(s) :
32854 - Fixatiori device, internal, pin
33701 - Prosthesis, elbow, internal, radial eomponenl
35966 - Prosthesis, inLernal, radial head

Declaration of Confor mity Preiiarcd Date: August 30, 2011

Revision: B
 Document Number: INST. 2.1.2.2
Revision: 2
Date Issued: 04/21 / 11
REF: SOP 2. 1.2 TECHNICAL FILE PROCEDURE Page: 3 of3

REV. DATE DESCRIPTION OF CHANGE

1 05/25/10 New

2 04/21111 Added additional column and note for GMDN codes for clarity.

Declaration of Conformity Prep:wed Date: August 30, 2011

Revision: B