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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 K113571
Device Name GMK RESUFACING PATELLA SIZE 4
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 Received12/02/2011
Decision Date 01/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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