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510(k) K955620

PRIME CEMENTED CALCAR FEMORAL STEMS by Orthopaedic Innovations, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1996
Date Received
December 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Orthopaedic Innovations, Inc.

  • K020145 — ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM (April 15, 2002)
  • K983881 — COBRA EXTERNAL FIXATOR (December 4, 1998)
  • K962646 — PRIME MODULAR ENDO HEAD (September 23, 1996)
  • K960014 — PRACTIFIX EXTERNAL FIXATION SYSTEM (March 18, 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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