Navigated Anterolateral Disc Prep Instruments

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 Anterolateral Disc Prep Instruments.

Pre-market Notification Details

Device IDK192336
501k NumberK192336
Device Name:Navigated Anterolateral Disc Prep Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis,  TN  38132
ContactParwinder Singh
CorrespondentParwinder Singh
Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis,  TN  38132
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-28
Decision Date2019-11-22

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