StealthStation S8 Spine Software V1.0.0

Orthopedic Stereotaxic Instrument

MEDTRONIC NAVIGATION

The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Stealthstation S8 Spine Software V1.0.0.

Pre-market Notification Details

Device IDK170011
510k NumberK170011
Device Name:StealthStation S8 Spine Software V1.0.0
ClassificationOrthopedic Stereotaxic Instrument
Applicant MEDTRONIC NAVIGATION 826 COAL CREEK CIRCLE Louisville,  CO  80027
ContactJohn Connor
CorrespondentJohn Connor
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 Received2017-01-03
Decision Date2017-05-01
Summary:summary

NIH GUDID Devices

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00763000242923 K170011 000

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