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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 K032950
Device Name GEM INSET PATELLAR COMPONENT
Applicant
Kinamed, Inc.
820 Flynn Rd.
Camarillo,  CA  93012
Applicant Contact VINEET SARIN
Correspondent
Kinamed, Inc.
820 Flynn Rd.
Camarillo,  CA  93012
Correspondent Contact VINEET SARIN
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/22/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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