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510(k) K222278

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation by Corentec Co., Ltd. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2022
Date Received
July 29, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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