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510(k) K071583

CERMET III ACETABULAR CUP SYSTEM by Implants International, Ltd. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2007
Date Received
June 8, 2007
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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