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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 K090988
Device Name GMK TOTAL KNEE SYSTEM
Applicant
Medacta International S.A.
13721 Via Tres Vista
San Diego,  CA  92129
Applicant Contact NATALIE J KENNEL
Correspondent
Medacta International S.A.
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact NATALIE J KENNEL
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/07/2009
Decision Date 07/10/2009
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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