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510(k) K930595

AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY by Orthomet, Inc. — Product Code JWH

Clearance Details

Decision
SN ()
Decision Date
October 22, 1993
Date Received
February 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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  • K925536 — HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (January 7, 1994)

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