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510(k) K160907

DePuy Actis DuoFix Hip Prosthesis by Depuy(Ireland) — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2016
Date Received
April 1, 2016
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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