Navigated T2 STRATOSPHERE Inserters And Navigated Templates

Orthopedic Stereotaxic Instrument

Medtronic Sofamor Danek, USA Inc

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa Inc with the FDA for Navigated T2 Stratosphere Inserters And Navigated Templates.

Pre-market Notification Details

Device IDK191039
510k NumberK191039
Device Name:Navigated T2 STRATOSPHERE Inserters And Navigated Templates
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Sofamor Danek, USA Inc 1800 Pyramid Place Memphis,  TN  38132
ContactElizabeth Hamilton
CorrespondentElizabeth Hamilton
Medtronic Sofamor Danek, USA Inc 1800 Pyramid Place Memphis,  TN  38132
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-19
Decision Date2019-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000091255 K191039 000
00763000091248 K191039 000
00643169611900 K191039 000
00643169611894 K191039 000
00643169611870 K191039 000
00643169611863 K191039 000
00643169611825 K191039 000
00763000168711 K191039 000

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