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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 K152431
Device Name LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
Applicant
Waldemar Link GmbH & Co. KG
Barkhausenweg 10
Hamburg,  DE 22339
Applicant Contact HELMUT D. LINK
Correspondent
Waldemar Link GmbH & Co. KG
Barkhausenweg 10
Hamburg,  DE 22339
Correspondent Contact Andre Von Malotki
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Code
HSX  
Date Received08/26/2015
Decision Date 05/09/2016
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
Recalls CDRH Recalls
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