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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 K172219
Device Name Mako Total Knee Application
Applicant
MAKO Surgical Corp.
2555 Davie Road
Fort Lauderdale,  FL  33317
Applicant Contact Karen Ariemma
Correspondent
MAKO Surgical Corp.
2555 Davie Road
Fort Lauderdale,  FL  33317
Correspondent Contact Karen Ariemma
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/24/2017
Decision Date 09/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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