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Design Examination
No. CE 526060
Issued to:
Biomet UK Limited
Waterton Industrial Estate
Bridgend
CF313XA
United Kingdom
In respect of:
Copeland and Copeland Thin Shell Shoulder System
On the basis of our examination under the requirements of Council Directive 93/42/EEC, Annex II, Section 4 and
Commission Directive 200S/S0/EC
For and on behalf of the British Standards Institution, a Notified Body for the above Directive (Notified Body Number
0086):
David Ford, Director, Healthcare and Testing Services
Date: 27 Oct 2009
First Issued: 10 Oct 2008
Expiration Date: 9 Oct 2013
Page: 1 of 4
Conditions of Approval
Validity of this certificate is conditional on the ~uality system being maintained to the requirements of the Directive.
raising standards worldwide
TM
The British Standards Institution. trading as BSI, a company incorporated in the United Kingdom by Royal Charter and with its place of business at Kitemark House, Maylands Avenue, Hemel Hempstead HP2 4SQ
United Kingdom Tel: +44 (0)8450 765600 Web: www.bsigroup.com. BSI Group Headquarters: 389 Chisvvick High Road, London W4 4AL Tel: +44 (0)20 8996 9000.
PS102310509/AP
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Supplementary Information to CE 526060
Issued to:
Biomet UK Limited
Bridgend
United Kingdom
CATALOGUE NO.
DESCRIPTION
114310
Humeral Component, Size 1 (Small)
114302
Humeral Component, Size 2 (Small Plus)
114311
Humeral Component, Size 3 (Standard)
114320
Humeral Component, Size 4 (Standard Plus)
114312
Humeral Component, Size 5 (Large)
114306
Humeral Component, Size 6 (Extra Large Double Minus)
114307
Humeral Component, Size 7 (Extra Large Minus)
114317
Humeral Component, Size 8 (Extra Large)
114313
Glenoid Component, Small
114314
Glenoid Component, Standard
114315
Glenoid Component, Extra Deep
114316
Glenoid Component, Standard, All Polyethylene
114318
Glenoid Component, Large
First Issued: 10 Oct 2008
Date:
27 Oct 2009
Expiration Date: 9 Oct 2013
Page: 2of4
raising standards worldwide
1M
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The British Standards Institution, trading as BSt a company incorporated in the United Kingdom by Royal Charter and with its place of business at Kitemark House, Maylands Avenue, Hemel Hempstead HP2 4SQ
United Kingdom Tel: +44 (0)8450 765600 Web: www.bsigroup.com. BSI Group Headquarters: 389 Chiswick High Road, London W4 4AL Tel: +44 (0)20 8996 9000.
PS10231OS09IAP
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Supplementary Information to CE 526060
Issued to:
Biomet UK Limited
Bridgend
United Kingdom
CATALOGUE NO.
DESCRIPTION
TS-114310
Thin Shell Humeral Component Size 1 (Small)
TS-114302
Thin Shell Humeral Component Size 2 (Small plus)
TS-114311
Thin Shell Humeral Component Size 3 (Standard)
TS-114320
Thin Shell Humeral Component Size 4 (Standard plus)
TS-114312
Thin Shell Humeral Component Size 5 (Large)
TS-114306
Thin Shell Humeral Component Size 6 (Extra large Double minus)
TS-114307
Thin Shell Humeral Component Size 7 (Extra large minus)
TS-114317
Thin Shell Humeral Component Size 8 (Extra large)
Date:
First Issued: 10 Oct 2008
27 Oct 2009
Expiration Date: 9 Oct 2013
Page: 30f4
raising standards worldwide
TM
=---.
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•
The British Standards Institution, trading as BSt. a company incorporated in the United Kingdom by Royal Charter and with its place of business at Kitemark House, Maylands Avenue, Hemel Hempstead HP2 4SQ
United Kingdom Tel: ...44 (0)8450 765600 Web: www.bsigroup.com. BSI Group Headquarters: 389 Chiswick High Road, London W4 4AL Tel: ...44 (0)20 8996 9000.
PSl02310509/AP
Supplementary Information to CE 526060
Issued to:
Biomet UK Limited
Bridgend
United Kingdom
History of Certificate
Date
BSI Reference
Action
10 October 2008
10091985
First issue
27 October 2009
10109769
Scope changed to include'Copeland Thin Shell
Shoulder System'
Addition of part number family (TS-114310)
First Issued: 10 Oct 2008
Date:
27 Oct 2009
Expiration Date: 9 Oct 2013
Page: 4 of 4
raising standards worldwide
-_
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1M
•
The British Standards Institution, trading as BSI, a company incorporated in the United Kingdom by Royal Charter and with its place of business at Kitemark House, Maylands Avenue, Hemel Hempstead HP2 4SQ
United Kingdom Tel: +44 (0)8450 765600 Web: www.bsigroup.com. BSI Group Headquarters: 389 Chiswick High Road, London W4 4AL Tel: +44 (0)20 8996 9000.
PS1023/0S09/AP