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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 K150544
Device Name Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
Applicant
Aesculap Implant Systems, LLC
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Julie Tom Wing
Correspondent
Aesculap Implant Systems, LLC
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Lisa M Boyle
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/03/2015
Decision Date 05/29/2015
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
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