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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, SA
13721 VIA TRES VISTA
SAN DIEGO,  CA  92129
Applicant Contact NATALIE J KENNEL
Correspondent
MEDACTA INTERNATIONAL, SA
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
Recalls CDRH Recalls
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