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510(k) K962557

GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT by Smith & Nephew Richards, Inc. — Product Code JWH

Clearance Details

Decision
SN ()
Decision Date
December 5, 1996
Date Received
July 1, 1996
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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  • K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM (August 19, 1996)
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  • K955767 — COFIED MODULAR SHOULDER SYSTEM (April 8, 1996)
  • K960094 — REFLECTION DUAL DIMENSION SHELL (March 27, 1996)

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