Mako Total Knee 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 Knee Application.

Pre-market Notification Details

Device IDK220459
510k NumberK220459
Device Name:Mako Total Knee Application
ClassificationOrthopedic Stereotaxic Instrument
Applicant Mako Surgical Corp. 3365 Enterprise Ave. Weston,  FL  33331
ContactEmily Dimambro
CorrespondentEmily Dimambro
Mako Surgical Corp. 3365 Enterprise Ave. Weston,  FL  33331
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-17
Decision Date2022-04-15

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