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510(k) K220628

LINK Endo-Model EVO Knee System by Waldemar Link GmbH & Co. KG — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2022
Date Received
March 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

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