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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
Applicant Contact JULIE TOM WING
Correspondent
AESCULAP IMPLANT SYSTEM, INC.
3773 CORPORATE PWKY.
CENTER VALLEY,  PA  18034
Correspondent Contact JULIE TOM WING
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/26/2012
Decision Date 10/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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