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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, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K040268
Device Name DEPUY PRESERVATION UNICONDYLAR TIBIA
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact ABRAHAM WRIGHT
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact ABRAHAM WRIGHT
Regulation Number888.3530
Classification Product Code
HRY  
Date Received02/05/2004
Decision Date 05/05/2004
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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