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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K072806
Device Name MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
Applicant
MAKO SURGICAL CORP.
2555 DAVIE RD.
FORT LAUDERDALE,  FL  33317
Applicant Contact WILLIAM TAPIA
Correspondent
MAKO SURGICAL CORP.
2555 DAVIE RD.
FORT LAUDERDALE,  FL  33317
Correspondent Contact WILLIAM TAPIA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/01/2007
Decision Date 01/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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