Spine And Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Plann

Orthopedic Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Spine And Trauma Navigation System, Spine & Trauma 3d Navigation, Instrument Selection, Fluoro 3d, Registration Software Fluoro 3d, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Plann.

Pre-market Notification Details

Device IDK212245
510k NumberK212245
Device Name:Spine And Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Plann
ClassificationOrthopedic Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-19
Decision Date2022-04-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481143244 K212245 000
04056481142728 K212245 000
04056481142742 K212245 000
04056481143114 K212245 000
04056481143176 K212245 000
04056481143183 K212245 000
04056481143190 K212245 000
04056481143206 K212245 000
04056481143213 K212245 000
04056481143220 K212245 000
04056481143237 K212245 000
04056481143954 K212245 000

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