Synergy Cranial V2.2.9, StealthStation Cranial V3.1.4

Neurological Stereotaxic Instrument

Medtronic Navigation, Inc.

The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Synergy Cranial V2.2.9, Stealthstation Cranial V3.1.4.

Pre-market Notification Details

Device IDK221087
510k NumberK221087
Device Name:Synergy Cranial V2.2.9, StealthStation Cranial V3.1.4
ClassificationNeurological Stereotaxic Instrument
Applicant Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville,  CO  80027
ContactSilver Wirth
CorrespondentSilver Wirth
Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville,  CO  80027
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-13
Decision Date2022-06-10

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