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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 K151008
Device Name LINK® MEGASYSTEM-C®
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 Stefanie Reimers
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JDI   LWJ   LZO  
Date Received04/15/2015
Decision Date 08/26/2015
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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