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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 K093425
Device Name MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
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
OLO  
Date Received11/03/2009
Decision Date 02/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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