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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
Recalls CDRH Recalls
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