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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 K211768
Device Name LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
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 Sheridan Powell
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JDI   LWJ   LZO  
Date Received06/08/2021
Decision Date 06/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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