StealthStation System With Cranial Software

Neurological Stereotaxic Instrument

MEDTRONIC NAVIGATION, INC.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Stealthstation System With Cranial Software.

Pre-market Notification Details

Device IDK153660
510k NumberK153660
Device Name:StealthStation System With Cranial Software
ClassificationNeurological Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville,  CO  80027
ContactAugusta Henao
CorrespondentAugusta Henao
MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Lousville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169625631 K153660 000
00763000517335 K153660 000
00763000299927 K153660 000
00763000299972 K153660 000
00763000253165 K153660 000
00763000095741 K153660 000
00763000095758 K153660 000
00763000095819 K153660 000
00643169625532 K153660 000
00643169625570 K153660 000
00763000517274 K153660 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.