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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K220628
Device Name LINK Endo-Model EVO Knee System
Applicant
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Applicant Contact Stefanie Fuchs
Correspondent
LinkBio Corp.
69 King St.
Dover,  NJ  07801
Correspondent Contact Terry Powell
Regulation Number888.3510
Classification Product Code
KRO  
Date Received03/04/2022
Decision Date 05/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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