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510(k) K925883

OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS by Osteonics Corp. — Product Code JDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1993
Date Received
November 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

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  • K962007 — PROTRUSION CAGES (August 1, 1996)
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