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510(k) K020145

ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM by Orthopaedic Innovations, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2002
Date Received
January 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Orthopaedic Innovations, Inc.

  • K983881 — COBRA EXTERNAL FIXATOR (December 4, 1998)
  • K962646 — PRIME MODULAR ENDO HEAD (September 23, 1996)
  • K960014 — PRACTIFIX EXTERNAL FIXATION SYSTEM (March 18, 1996)
  • K955620 — PRIME CEMENTED CALCAR FEMORAL STEMS (February 20, 1996)
  • K955751 — PRIME FEMORAL CEMENT PLUG (January 26, 1996)
  • K953033 — PRIME CEMENTED SMALL FEMORAL STEM (September 13, 1995)
  • K940328 — PRIME CEMENTED HIP SYSTEM (April 7, 1995)

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