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510(k) K083566

R3 CONSTRAINED LINER, CONSTRAINED LINER by Smith & Nephew, Inc. — Product Code KWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2009
Date Received
December 3, 2008
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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Other clearances for product code KWZ

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  • K163497 — EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset (March 2, 2017)
  • K161610 — EXPRT Revision Hip System (November 9, 2016)
  • K122139 — SMITH & NEPHEW R3 CONSTRAINED LINERS (October 16, 2012)
  • K111635 — SMITH & NEPHEW RJ CONSTRAINED LINERS (September 9, 2011)
  • K101730 — LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (December 3, 2010)
  • K072121 — TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (January 7, 2008)
  • K071059 — DEPUY SPA POROUS COATED PROXIMAL SLEEVE (November 9, 2007)