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510(k) K915350

HYDROXYAPATITE INFINITY TROCHANTERIC MODULE by Dow Corning Wright — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1992
Date Received
November 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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  • K930190 — ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP (August 2, 1993)

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