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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 K143635
Device Name KINETIS Total Knee System
Applicant
Mako Surgical
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Applicant Contact JONATHAN REEVES
Correspondent
Mako Surgical
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Correspondent Contact JONATHAN REEVES
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received12/22/2014
Decision Date 02/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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