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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 K121064
Device Name MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
Original Applicant
MAKO SURGICAL CORPORATION
2555 davie road
fort lauderdale,  FL  33317
Original Contact dionne sanders
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/06/2012
Decision Date 06/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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