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510(k) K162127

Bencox M Stem Lateralized & Bencox Mirabo Cup System by Corentec Co., Ltd. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2016
Date Received
August 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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