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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 K122985
Device Name COLUMBUS REVISION KNEE SYSTEM
Applicant
AESCULAP IMPLANT SYSTEM, INC.
3773 corporate pwky.
center valley,  PA  18034
Contact julie tom wing
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/26/2012
Decision Date 10/26/2012
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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