Mako Total Hip Application

Orthopedic Stereotaxic Instrument

Mako Surgical Corp.

The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Total Hip Application.

Pre-market Notification Details

Device IDK193128
510k NumberK193128
Device Name:Mako Total Hip Application
ClassificationOrthopedic Stereotaxic Instrument
Applicant Mako Surgical Corp. 2555 Davie Rd Fort Lauderdale,  FL  33317
ContactLiza Gordillo
CorrespondentLiza Gordillo
Mako Surgical Corp. 2555 Davie Rd Fort Lauderdale,  FL  33317
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-12
Decision Date2020-02-02

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