FDA 510(k) Application Details - K142530

Device Classification Name Orthopedic Stereotaxic Instrument

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510(K) Number K142530
Device Name Orthopedic Stereotaxic Instrument
Applicant MAKO SURGICAL CORPORATION
2555 DAVIE ROAD
FORT LAUDERDALE, FL 33317 US
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Contact Jonathan Reeves
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Regulation Number 882.4560

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Classification Product Code OLO
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Date Received 09/09/2014
Decision Date 09/16/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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