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 IDK170891
510k NumberK170891
Device Name:Mako Partial Knee Application
ClassificationOrthopedic Stereotaxic Instrument
Applicant MAKO Surgical Corp. 2555 Davie Rd Fort Lauderdale,  FL  33317
ContactShikha Khandelwal
CorrespondentShikha Khandelwal
MAKO Surgical Corp. 2555 Davie Rd Fort Lauderdale,  FL  33317
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-27
Decision Date2017-05-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848486016319 K170891 000

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