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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 K023416
Device Name MODIFICATION TO VKS KNEE SYSTEM
Original Applicant
PLUS ORTHOPEDICS
6055 lusk blvd.
san diego,  CA  92121 -2700
Original Contact louise focht
Regulation Number888.3560
Classification Product Code
JWH  
Date Received10/11/2002
Decision Date 11/08/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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