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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, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K070849
Device Name DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact NANCY FRIDDLE
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact NANCY FRIDDLE
Regulation Number888.3560
Classification Product Code
NPJ  
Subsequent Product Code
HRY  
Date Received03/28/2007
Decision Date 06/26/2007
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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