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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 K163311
Device Name GMK Revision Femoral Distal Augmentation
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro (Ch),  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Mapi USA, Inc.
2343 Alexandria Dr., Suite 100
Lexington,  KY  40504
Correspondent Contact Elizabeth Rose
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Code
JWH  
Date Received11/23/2016
Decision Date 12/21/2016
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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