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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 K083772
Device Name COLUMBUS REVISION KNEE SYSTEM
Applicant
AESCULAP IMPLANT SYSTEM, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact LISA M BOYLE
Correspondent
AESCULAP IMPLANT SYSTEM, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact LISA M BOYLE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/18/2008
Decision Date 06/04/2009
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
Recalls CDRH Recalls
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