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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 K071220
Device Name COLUMBUS TOTAL KNEE SYSTEM AS
Applicant
AESCULAP IMPLANT SYSTEMS, INC.
3773 CORPORATE PKWY.
CENTER VALLEY,  PA  18034
Applicant Contact MATTHEW M HULL
Correspondent
AESCULAP IMPLANT SYSTEMS, INC.
3773 CORPORATE PKWY.
CENTER VALLEY,  PA  18034
Correspondent Contact MATTHEW M HULL
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/02/2007
Decision Date 06/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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