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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 K032151
Device Name DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
Applicant
DEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact CHERYL HASTINGS
Correspondent
DEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/14/2003
Decision Date 09/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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