MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)

Neurological Stereotaxic Instrument

MAKO SURGICAL CORP.

The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Surgical Tactile Guidance System (tgs).

Pre-market Notification Details

Device IDK072806
510k NumberK072806
Device Name:MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
ClassificationNeurological Stereotaxic Instrument
Applicant MAKO SURGICAL CORP. 2555 DAVIE RD. Fort Lauderdale,  FL  33317
ContactWilliam Tapia
CorrespondentWilliam Tapia
MAKO SURGICAL CORP. 2555 DAVIE RD. Fort Lauderdale,  FL  33317
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-01
Decision Date2008-01-24
Summary:summary

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