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510(k) K112556

ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS by Howmedica Osteonics Corp. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2011
Date Received
September 2, 2011
Clearance Type
Special
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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