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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 K091998
Device Name ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
Applicant
Mako Surgical Corp.
2555 Davie Rd., Suite 110
Ft. Lauderdale,  FL  33317
Applicant Contact WILLIAM TAPIA
Correspondent
Mako Surgical Corp.
2555 Davie Rd., Suite 110
Ft. Lauderdale,  FL  33317
Correspondent Contact WILLIAM TAPIA
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/02/2009
Decision Date 09/28/2009
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
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