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510(k) K211866

Bencox THR System by Corentec Co., Ltd. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2021
Date Received
June 16, 2021
Clearance Type
Special
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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