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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 K172301
Device Name Mako Partial Knee Application
Applicant
Mako Surgical Corp.
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Applicant Contact Andrea Dwyer Steiner
Correspondent
Mako Surgical Corp.
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Correspondent Contact Andrea Dwyer Steiner
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/31/2017
Decision Date 11/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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