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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 K120955
Device Name COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM
Original Applicant
AESCULAP IMPLANT SYSTEMS, LLC
3773 corporate parkway
center valley,  PA  18034
Original Contact kathy a racosky
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
KRO  
Date Received03/30/2012
Decision Date 12/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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