StealthStation S8 Cranial V2.0

Neurological Stereotaxic Instrument

Medtronic Navigation

The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Stealthstation S8 Cranial V2.0.

Pre-market Notification Details

Device IDK212397
510k NumberK212397
Device Name:StealthStation S8 Cranial V2.0
ClassificationNeurological Stereotaxic Instrument
Applicant Medtronic Navigation 826 Coal Creek Circle Louisville,  CO  80027
ContactCarey Brenner
CorrespondentCarey Brenner
Medtronic Navigation 826 Coal Creek Circle Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2021-12-22

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