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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 K111283
Device Name GMK REVISION HYBRID LINERS
Applicant
Medacta International
4725 Calle Quetzal Unit B
Camarillo,  CA  93012
Applicant Contact ADAM GROSS
Correspondent
Medacta International
4725 Calle Quetzal Unit B
Camarillo,  CA  93012
Correspondent Contact ADAM GROSS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/06/2011
Decision Date 05/27/2011
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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