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510(k) K240639

PINNACLETM Constrained Acetabular Liners by Depuy Ireland UC — Product Code KWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2024
Date Received
March 6, 2024
Clearance Type
Special
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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  • 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)
  • K083566 — R3 CONSTRAINED LINER, CONSTRAINED LINER (March 3, 2009)
  • K072121 — TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (January 7, 2008)
  • K071059 — DEPUY SPA POROUS COATED PROXIMAL SLEEVE (November 9, 2007)