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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K143752
Device Name Total Knee Application (TKA)
Applicant
Mako Surgical Corp.
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Applicant Contact JONATHAN REEVES
Correspondent
Mako Surgical Corp.
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Correspondent Contact JONATHAN REEVES
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/31/2014
Decision Date 08/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT02058069
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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