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List of Significant Subcontractors Recognised as being involved in seivices relating to the product covered by: Certificate No. Date: CE 53820 Issued to: 5 May 2005 DePuy Spine . Raynham Subcontractor DePuy (Ireland} .Limited• · Ringaskiddy Cork Ireland Waldemar link GrnpH & Co. KG Barkhausenweg ·Hamburg Germany 22339 DePuy Spine 365 Ravendale Road Mountain View CA94043 USA Titan Scan Systems 920 Activity Road, Suite D San Diego CA 92121 USA DePuy Spine Inc St Anthony's Road Leeds United Kingdom LS11 8DT BS! Product Services Service(s) supplied Manufacture Sterilization Design Page: 1of3 Mayianch Av<!nl!f;, Hemel Hernp>tead. Hertfordshire HP2 4SQ United Kin9dom Ti!I +'i•t (Ofi442 230•142 www.b.si-gio!x1i.cQrG Product Services ES; 38.9 ChLl..Vid: Hgh London W4 4Af. T<-:i· {L\}l.08 9!'.Jf; '100(; PSOS9/02JSIEF
Transcript of List of Significant Subcontractors · San Diego, to the list of significant subcontractors for...
List of Significant Subcontractors
Recognised as being involved in seivices relating to the product covered by:
Certificate No.
Date:
CE 53820
Issued to:
5 May 2005
DePuy Spine .
Raynham
Subcontractor
DePuy (Ireland} .Limited• · Ringaskiddy Cork Ireland
Waldemar link GrnpH & Co. KG Barkhausenweg
·Hamburg Germany 22339
DePuy Spine 365 Ravendale Road Mountain View CA94043 USA
Titan Scan Systems 920 Activity Road, Suite D San Diego CA 92121 USA
DePuy Spine Inc St Anthony's Road Leeds United Kingdom LS11 8DT
BS! Product Services
Service(s) supplied
Manufacture
Sterilization
Design
Page: 1of3
Mayianch Av<!nl!f;, Hemel Hernp>tead. Hertfordshire HP2 4SQ United Kin9dom Ti!I +'i•t (Ofi442 230•142 www.b.si-gio!x1i.cQrG
Product Services ES; H•.:i~itJ:1iJ;;rt1.0'.r;,: 38.9 ChLl..Vid: Hgh London W4 4Af. T<-:i· {L\}l.08 9!'.Jf; '100(; PSOS9/02JSIEF
Full Quality Assurance No. CE 53820
Issued to:
DePuy Spine. 325 Paramount Drfve , Raynham Massachusetts 02767 USA
In respect of: ~; :· ;·~~c ~ ,;•;, .. } .·· • .• ... ·,.. i' The design, development and manufacture of spinal implant systems and instrumentation systems, synttt~«~ ~~rt~Url:(~m~\~ri~f;~r.t4·~rn~.ntd~U~ery~y~~erns~ • ··: .. · .. ··
on the basis of our examination under the requirements of Council Directive 93/42/EEC, Annex II, Section 3.2.
For and on behalf of the British Standards Institution, a Notified Body for the above Directive (Notified Body Number . 0086):
First Issued: 4 Mar 2000
Expiration Date: 3 Mar 2010
Conditions of Approval
Date: 5 May 2005
Page: 1of1
Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive. This approval excludes all produets designed and/or manufactured by a third party on behalf of the company named on this certificate, unless. specifically agreed with BS!.
Product Services
BS! Product ServkN MBy!ands iwanue, H«rnel Hempstead, Hertfordshire HP2 4SQ Unit&d Kinqdnrn ·1e1 +~M {0)1442 230442 w11vw,bs~~glob~~J.corn
BS! l-lnn;p Ht: .. ;;.!q11a!F,rs. 38J (hi<>;.»;:d:. High He~1d, Lx1d(ln '~A/15 <1AL re.t \o;;zng 996 9GfJC!
History
CN=Cathie Stoffell/OU=TGA/O=Health
Certificate issued under:
Conformity assessment procedure:
Source of certification:
Certificate number:
Certificate issue date: (dd/mm/yyyy)
Certificate expiry date: (dd/mm/yyyy)
Certificate re-issue date: (dd/mm/yyyy)
Restrictions on scope:
Council Directive 93/42/EEC (MOD)
Schedule 3 Part 1 (Annex 11)
BSI Product Services [0086] Lookup!
CE 53820
0410312000
03/03/2010
0510512005
Restriction on conformity assessment procedure: Full Quality Assurance Certificate. Note: For Class Ill a Design Examination Certificate must be submitted with the Device Application.
EC Certificate- CE 53820_DePuy Spine_Exp 3Mar10.pdf
Depuy Australia Pty Ltd - Prosthesis, internal, spine, disc
Evidence identifier:
Submission identifier:
Version number:
Sponsor's own reference:
Agent name:
Sponsor name:
Manufacturer name:
Status Versioned
021112-WEBE-5FT7L4
DV-2005-5669
10
· . DePuy Spine Inc Annex II
Johnson & Johnson Medical Pty Ltd T/A Depuy Australia
Depuy Spine Inc. (United States Of America)[42419]
Manufacturer address as on certification: 325 Paramount Drive Raynham Massachusetts 02767 United States Of America
Type of product:
0 This certification is to support an application for an in vitro diagnostic medical device (IVD)
e This certification is to support an application for a medical device that is not an in vitro diagnostic medical device (IVD)
History of Quality Assurance Certificate
Certificate No:
Issue Date:
Issued to:
Date
12 April .2011
CE 53820
DePuySpine
Raynham
USA
BSI Reference No.
7652447
raising standards worldwide'"
Action Revision of scope, from 'The d$sign, development and manufacture of spinal implant systems and instrumentation systems, synthetic bone graft material, spinalcement and cement delivery systems and accessory needles' to 'The design, development and manufacture of spinal implant systems and instrumentation systems, bovine-derived bone graft material, soinal cement deliverv svstems and accessorv needles.'
Page3 of3
The British Standards Institution, Kitemark House, Maylands Avenue. Hemei Heffi13stead, HP2 4SQ United Kingdom Tei: +44 (0)8450 765500 Web: www.bsigroup.com The fkitiSh Standards lnstitulkm ·15 mcorporateiJ by Roya! Cha1 te=r. Prindpa! Office: 339 01isviick High Road. taodori W4 4Al UK· Te!~ +44 (0)20 -B995 9000. ?S 102~1~ 2 HVA.f'
History of Quality Assurance Certificate
Certificate No:
Issue Date:
Issued to:
Date
7 April 2008
13 August 2008
6 October 2008
27 March 2009
26 February 2010
CE 53820
DePuySpine
Raynham
USA
BSI Reference No.
7177220
7217964
7265920
7341322
7459365
raising standards worldwide"'
Action
Extension to scope to include "Spinal Cement"
Addition of subcontractorDisc-o-Tech Medical Technologies Ltd., for the activities of de$ign .and manufacture
Removal of DePuy Orthopaedics, Inc. from the Ust of significant subcontractors for manufacturing. Addition of BeamOne to the list of significant subcontractors for sterilization and Symmetry Medical, Inc. to the list of significant subcontractors for manufacturina.
Addition of Mediplast Israel Ltd, Sor-Vian Radiation Ltd, and Leoni Studer AG Studer Hard to the list of significant subcontractors for sterilization.
Addition of DePuy Motion SARL to the list of significant subcontractors for manufacture. Addition of design activity for existing subcontractor DePuy Spine SARL. Addition of Sterigenics, San Diego, to the list of significant subcontractors for E-beam sterilization. Removal of Disc-0-Tech Medical, Symmetry Medical, and DePuv Spine Leeds from the list of significant subcontractors.
Certificate renewal
Inclusion of 'accessory needles' in the scope
Addition of 'DePuy Int. for EU Rep.
Deletion of Waldemar Link GmbH & Co., KG & J & J Medical, Germany.
Minor changes to several sub contractors' addresses to match their current ISO 13485 certificates.
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The British Standards Institution, Kitemark House, Mayiands Avenue. Heme! Hempstead. HP2 45Q United Kingdom Te!: +44 (0}8450 765600 Web: vM•N.bsigroup.com The British Standards Institution is inrnrporate<l by Royal Chartor. Pnncipcl Office: 389 Chiswick High Road;tondon W4 4AL UK. Tei: +44 {0)20 8996 9000 ?S10Zli1ZWAP
History of Quality Assurance Certificate
Certificate No:
Issue Date:
Issued to:
Date
04 March 2000
01 November 2002
21 November 2003
18 August 2004
18 April 2005
5 May 2005
19 June 2006
20 March 2007
CE 53820
DePuySpine
Raynham
USA
BSI Reference No.
-
-
-
-
-
-
-
-
raising standards worldwide"'.
Action
First issue
DePuy Inc (Bridgewater) added as a subcontractor
DePuy Acromed, Inc (Jacksonville) removed from the list of subcontractors
Change of company name, ~hange of scope and addition of DePuy Spine (Mountain View), titan Scan Systems (San Diego) and DePuv Spine Inc (Leeds} to the list of subcontractors
Addition of DePuy (Ireland) Limited (Cork), Waldemar Link GmbH & Co. KG {Germany) and lsotron Pie (Reading) to the. list of subcontractors
Addition of Ethicon GmbH (Norderstedt}, Steris/lsomedix (Massachusetts), and DePuy Spine SARL (Switzerland) as subcontractors and five vear renewal
Alignment with CE 79912 following completion of SER for Healos II Devices and addition of Kensey Nash Corporation as a subcontractor for Animal Substances.
Addition of DePuy Orthopaedics New Bedford as a subcontractor for manufacture
Sub-contractor company name change from "Titan Scan Systems" to "BeamOne LLC" and typographical error correction to address of BeamOne LLC
Page 1 of3
The British Standards Institution, Kiteniar~- House, May!ands Avenue, Heme! Hempstead. HP2 4SQ United Kingdom Tel: +44 (Ol8450 765600 Web: 'iNwv-bsigroup.com The Bnt1sh S1andards tnstHutinri is !ncorpor.ated by Roy.al Charter. Princ1pat OffJce: 389 Chlsv/Jck High Road, London ~V4 4A.L V!C Tei: +44 ~0}.20 89% 9iJOO. PS1023!! 2 'lC/AP
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No.
Date:
Issued to:
Subcontractor
Beam One. LLC
CE 53820
12 Apr 2011
DePuySpine
Raynham
USA
500 West 4th Street Lima OH45804
RSI Leasing, Inc. dba Sterigenics 7695 Formula Place San Diego California 92121
raising standards worldwide,,..
S~rvice(s) supplied ·-------.-~. ----·----
Sterilization
E beam Sterilization.
Page: 4 of 4
The ·British Standards Institution, Kitemark House, Mayiands Avenue, Heme! Hempstead, HP2 4SQ United Kingdom Tel: +44 (0)8450 755600. Web: www.bsigroup.com The BHtish Standards !nstitttkin is inc:orporat-ed by Royai Charter. Principal Office: 389 OtlS"\.vic.k H!gh Rood, london 'N4 4At UK. Tel: +h4 \0)20- 89-96 9000. Pst0nn21o;AP
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No.
Date:
Issued to:
Subcontractor
CE 53820
12 Apr 2011.
DePuySpine
Raynham
USA
Steris lsomedix Services 435 Whitney Street Northborough Massachusetts 01532
Kensey Nash Corporation 735 Pennsylvania Ave. Exton PA 19341
Mediplast Israel Ltd. 7 Ha'yarkon Street P. 0. Box 13214 Industrial Zone Yavne 81227
Sor-Van Irradiation Ltd. Kiryat Soreq PO Box 214 Yavne 81800
raising standards worldwide""
Page: 3of4
Service(s) supplied
ETO Sterilization Gamma Sterili:Zation
Animal substances
Sterilization
Sterilization
The British Standards Institution, Kitemark House, Maylands Avenue, Hemel Hempstead, HP2 4SQ United Kingdom Tel: +44 (0)8450 765600 Web: www.bsigroup.com The British 5tandan:.ls. ir.s1Jwt;cn 6 incorpom!ed by Re:,,-.. ,! Charter. Pi'1rH:1p.a1 otke: 389 Chiswfck HTgh Read, London V./4 4AL UK. Tef: +44 (OJ2U 8~ 9000, ?}1V23ffJ1QrAP
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No.
Date:
Issued to:
Subcontractor
DePuySpine
CE 53820
12 Apr 2011
DePuySpine
Raynham
USA
365 Ravendale Road Mountain View CA94043
Service(s) supplied
Manufacture
BeamOne LLC Sterilization 9020 Activity Road, Suite D San Diego CA 92126
lsotron PLC Sterilization Marcus Close Tilehurst Reading Berkshire RG30 4EA
DePuy Inc. 50 Scotland Park Drive Bridgewater Massachusetts USA
raising standards worldwide™
Page: 2 of4
Distribution Packaging Inspection
The British Standards Institution, Kitemark House, rviaylands Avenue, Herne! Hempstead, HP2 4SQ United Kingdom Tel: +44 (0)8450 765600 Web: wAw.bsigroup:com 'fne British Standards lr;stltdion is incorp~ia1ed t;y Roya! Charter, Principal Offke: 389 Chisi.vick High Road, London V/4 4AL UK Tei: +44 (0}20 8996 9000. PS'!Q2'3·'12FJ/AP
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No.
Date:
Issued to:
Subcontra~or
Leoni Studer AG Studer Hard 4658 Daniken
CE 53820
12 Apr2011
DePuySpine
Raynham
USA
Service(s) supplied
Sterilization
DePuy International Limited EU Representative St Anthony's Road Leeds United Kingdom
DePuy Motion SARL Chemin Blanc 38 CH-2400 Le Lacie
DePuy Spine SARL Chemin Blanc 36 CH 2400 Le Locle
Manufacture
Design Manufacture
' __ §...V~~-~~~~---~----~,,.-~,--- -- :~·=::-::::.::.: :..·_·, __ -,_ .. -... _-.. _-~_··-.. -_-_-_"'"'_'_::::_''_''''_" -·-----~--~---~"'-'--------------------------· DePuy {Ireland) Lough beg Ringaskiddy Cork
_
Full Quality Assurance No. CE 53820
Issued to:
DePuySpine 325 Paramount Drive Raynham Massachusetts 02767 USA
In respect of:
The design, development and manufacture of spinal implant systems and instrumentation systems, bovine-derived bone graft material, spinal cement delivery systems and accessory needles
on the.basis of our examination under the requirements of Council Directive 93/42/EEC, Annex II, Section 3.2.
For and on behalf of the British Standards Institution, a Notified Body for the above Directive (Notified Body Number 0086): .
First Issued: 4 Mar 2000
Expiration Date: 3 Mar 2015
Conditions of Approval
Date: 12 Apr 2011
Page: 1of1
. Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI.
raising standards worldwide™
The.~ritish Standards Institution, Kitemark House, Maylands Avenue, Heme\ Hempstead, HP2 4SQ United Kingdom Tel: +44 (0)8450 765600 Web: www.bsigroup.com Tne Sriti-sh Standards institutlon is inC1..rporated hy Royal Charter. Prmcipaf Offtc~; 3.89 Chi$\i\ick High Ro.;;d, lcrrdon W4 4AL UK, Tel: +44 (0)20 S99S 9000. ?SHJ7.3f!J1mAP
03/12/2002
# Document Type
History
Status Versioned
Date received : 26/11/2002
Certificate printed : No
New Notification
Evidence identifier: 021112-WEBE-5FT7L4
Version number:
Sponsor's own reference: DePuy Acromed, Inc
Agent name:
Sponsor name: DEPUY AUST P/L
Manufacturer name: DEPUY ACROMED (United States Of America)[31232]
Manufacturer address as on certification: 325 PARAMOUNT DRIVE MASSACHUSETTS United States Of America S[ 91
Type of product:
0 This certification is to support an application for an in vitro diagnostic medical device (IVD)
e This certification is to support an application for a medical device that is not an in vitro diagnostic medical device (IVD)
Certificate issued under:
Conformity assessment procedure:
Source of certification:
Certificate number:
Certificate issue date: (dd/mm/yyyy)
Certificate expiry date: (dd/mm/yyyy)
Certificate re-issue date: (dd/mm/yyyy)
Restrictions on scope:
Council Directive 93/42/EEC (MOD)
Schedule 3 Part 1 (Annex 11)
BSI Product Services [0086] Lookup i
53820
04/04/2000
04/04/2005
Restriction.on conformity assessment procedure: Full Quality Assurance Certificate. Note: For Class Ill a Design Examination Certificate must be submitted with the Device Application.
Attached documents
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No.
Date:
Issued to:
Subcontractor
Ethicon GmbH
Norderstedt Germany 22851
DePuy Spine Chemin Blanc 36 .. CH 2400 Le Lode Switzerland
lsotron PLC Marcus Close Tilehurst Reading Berkshire United Kingdom RG304EA
DePuy Inc
CE 53820
5 May 2005
DePuy Spine
Raynham
. Service(s) supplied.
· 8terl1i:Z:ation
Sterilization
50 Scotland Park Drive Bridgewater Massachusetts
Distribution Final Inspection Packaging
USA 02324
Page: 2 of 3
Ma'flands Avenue, Heme! He<tfon:bilire HP2 45() United Kingdom Te! +44 (Oi1442 230442 W\N\l'v.bsi-globai.rnm
Product Services BS~ GWL>P Hi:-::idqu~n0fa· 389 C!ib-.vid, Hign f\o,;xi, lvt1Jo.n Wrt 4A!. Tel: (0)208 996 ~Xto
fc'f~N'!! .. __________________ ._....,......., __________ .,.... _______________ ,_..,
y.-.,
List of Significant Subcontractors
Recognised as being involved in services relating to the product covered by:
Certificate No.
Date:
Issued to:
Subcontractor
CE 53820
5 May2005
DePuy Spine
Raynham
Steris Corporation · ·· lsomedix Services 435 Whitney Str~t Northborough Massachusetts USA 01532
Kensey Nash Corporation 55 East Uwchlan Avenue Exton PA 19341 USA
BSI Product Services
Service(s) supplied
Animal substances
Page: 3 of 3
MoyLmtis /\v~nue1 Herne! Hemp~;tectd,.Herttordsh!r8 fiP2 4SQ Unt~ec.i Kingdom Tel +44\0)i4d/ 1.304'1:! www!isi-g!ob~Lcorn
Product Services P':liS9iD20S/EP
History of Quality Assurance Certificate
Certificate No:
Issue Date:
Issued to:
Date
I 04 March 2000
18 August 2004
18 April 2005
5May 2005
Product Services
CE 53820
5 May2005
DePuy Spine, Inc
Raynham·
'ttiange of eotri;pahy name, chang~'citsriope and additiorl.ofDePuy Spine (MQ4DJ~lr:iVJ~w), ijt(;ln Sci:!n Systel)1s (p(ln Diego) and DeP1.1y Spine Inc {Leeds) totne nsror:subcorittaetots · Addition of DePuy (Ireland) Limited {Cork), Waldemar Link GmbH & Co. KG German and lsotron Pie Readin to the list of subcontractors
Addition of Ethicon GmbH (Norderstedt), Steris/lsomedix (Massachusetts), and DePu S ine SARL Switzerland as subcontractors and five ear renewal
Alignment with CE 79912 following completion of SER for Healos II Devices and addition of Kense Nash Cor oration as a subcontractor for Animal Substances.
Page 1of1
BS! Pl'odud Servk<es Maylat1d1i /\vt:nuer H~m;:;l i·it1nrYstr-:>cid, Hertforrlshih:~ i IF2 4SQ United Kingdor;1
+44 {O! i 442 l3Q.:'f::Q wv ... v1,bsi-qlobaLconi
