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510(k) K230471

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface by Waldemar Link GmbH & Co. KG — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2023
Date Received
February 21, 2023
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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