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510(k) K223828

BENCOX Delta Option Heads by Corentec Co., Ltd. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2023
Date Received
December 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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