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510(k) K962646

PRIME MODULAR ENDO HEAD by Orthopaedic Innovations, Inc. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1996
Date Received
July 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Orthopaedic Innovations, Inc.

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  • K983881 — COBRA EXTERNAL FIXATOR (December 4, 1998)
  • 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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