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510(k) K150862

DePuy Actis Duofox Hip Prosthesis by DePuy Orthopaedics, Inc. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2015
Date Received
April 1, 2015
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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