NavLock Trackers

Orthopedic Stereotaxic Instrument

Medtronic Navigation

The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Navlock Trackers.

Pre-market Notification Details

Device IDK201327
510k NumberK201327
Device Name:NavLock Trackers
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Navigation 826 Coal Creek Circle Louisville,  CA  80027
ContactTaylor Gold West
CorrespondentTaylor Gold West
Medtronic Navigation 826 Coal Creek Circle Louisville,  CA  80027
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-19
Decision Date2020-06-18

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