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510(k) K150544

Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System by Aesculap Implant Systems, LLC — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2015
Date Received
March 3, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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