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510(k) K940328

PRIME CEMENTED HIP SYSTEM by Orthopaedic Innovations, Inc. — Product Code JDI

Clearance Details

Decision
SN ()
Decision Date
April 7, 1995
Date Received
January 24, 1994
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)
  • 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)

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