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510(k) K960014

PRACTIFIX EXTERNAL FIXATION SYSTEM by Orthopaedic Innovations, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1996
Date Received
January 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Orthopaedic Innovations, Inc.

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  • K983881 — COBRA EXTERNAL FIXATOR (December 4, 1998)
  • K962646 — PRIME MODULAR ENDO HEAD (September 23, 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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