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510(k) K143635

KINETIS Total Knee System by Mako Surgical — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2015
Date Received
December 22, 2014
Clearance Type
Traditional
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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