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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 K003182
Device Name ORTHOGENESIS LPS SYSTEM
Applicant
DEPUY, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact JANET G JOHNSON
Correspondent
DEPUY, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact JANET G JOHNSON
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
JDI  
Date Received10/11/2000
Decision Date 06/27/2001
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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