Clearance Summary
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 Planning Spine, Elements Spine Screw Planning received FDA 510(k) clearance under submission number K212245, sponsored by Brainlab AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-04-13.
- Submission: K212245
- Applicant / Sponsor: Brainlab AG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2022-04-13
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.