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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 K143179
Device Name The LINK® Endo-Model® Knee System
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 Thomas Mehler
Regulation Number888.3510
Classification Product Code
KRO  
Date Received11/04/2014
Decision Date 01/30/2015
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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