Anteralign(TM) Spinal System With Titan NanoLOCK Surface Technology Navigated 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 Anteralign(tm) Spinal System With Titan Nanolock Surface Technology Navigated Instruments.

Pre-market Notification Details

Device IDK221180
510k NumberK221180
Device Name:Anteralign(TM) Spinal System With Titan NanoLOCK Surface Technology Navigated Instruments
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-25
Decision Date2022-05-25

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