StealthStation Spinous Process Clamps

Orthopedic Stereotaxic Instrument

Medtronic Navigation

The following data is part of a premarket notification filed by Medtronic Navigation with the FDA for Stealthstation Spinous Process Clamps.

Pre-market Notification Details

Device IDK211442
510k NumberK211442
Device Name:StealthStation Spinous Process Clamps
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Navigation 826 Coal Creek Circle Louisville,  CO  80027
ContactVictoria Baldock
CorrespondentVictoria Baldock
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 Received2021-05-10
Decision Date2021-07-08

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