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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K142069
Device Name GMK EXTENSION
Applicant
Medacta International
1556 W. Carroll Ave.
Chicago,  IL  60607
Applicant Contact ADAM GROSS
Correspondent
Medacta International
1556 W. Carroll Ave.
Chicago,  IL  60607
Correspondent Contact ADAM GROSS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/30/2014
Decision Date 12/02/2014
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
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