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510(k) K161233

OXINIUM DH Fermoral Heads by Smith & Nephew, Inc. — Product Code MBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2016
Date Received
May 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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