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510(k) K962002

AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM by Exactech, Inc. — Product Code JDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1996
Date Received
May 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)
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