Mako Partial 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 Partial Knee Application.

Pre-market Notification Details

Device IDK172301
510k NumberK172301
Device Name:Mako Partial Knee Application
ClassificationOrthopedic Stereotaxic Instrument
Applicant MAKO Surgical Corp. 2555 Davie Rd Fort Lauderdale,  FL  33317
ContactAndrea Dwyer Steiner
CorrespondentAndrea Dwyer Steiner
MAKO Surgical Corp. 2555 Davie Rd Fort Lauderdale,  FL  33317
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-31
Decision Date2017-11-02
Summary:summary

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