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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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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