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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 K112507
Device Name RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
Applicant
MAKO SURGICAL CORPORATION
2555 DAVIE ROAD
FORT LAUDERDALE,  FL  33317
Applicant Contact DIONNE SANDERS
Correspondent
MAKO SURGICAL CORPORATION
2555 DAVIE ROAD
FORT LAUDERDALE,  FL  33317
Correspondent Contact DIONNE SANDERS
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/30/2011
Decision Date 03/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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