NavLock Trackers, Robotic Reference Frame

Orthopedic Stereotaxic Instrument

Medtronic Navigation

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

Pre-market Notification Details

Device IDK182104
510k NumberK182104
Device Name:NavLock Trackers, Robotic Reference Frame
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Navigation 826 Coal Creek Circle Louisville,  CO  80027
ContactJainam Shah
CorrespondentJainam Shah
Medtronic Navigation 826 Coal Creek Circle Louisville,  CO  80027
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-03
Decision Date2018-11-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000231835 K182104 000
00763000231521 K182104 000
00763000156626 K182104 000
00763000123185 K182104 000
00763000123178 K182104 000
00763000423094 K182104 000

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