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510(k) K071059

DEPUY SPA POROUS COATED PROXIMAL SLEEVE by DePuy Orthopaedics, Inc. — Product Code KWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2007
Date Received
April 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3310
Review Panel
OR
Submission Type

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  • K111635 — SMITH & NEPHEW RJ CONSTRAINED LINERS (September 9, 2011)
  • K101730 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (December 3, 2010)
  • K083566 — R3 CONSTRAINED LINER, CONSTRAINED LINER (March 3, 2009)
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