FDA 510(k)

Spine & Trauma Navigation Instruments

N.º K: K252562 · 2025-09-12

Fecha de decisión2025-09-12

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Spine & Trauma Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K252562. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Spine & Trauma Navigation Instruments?

Spine & Trauma Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Brainlab AG. The 510(k) number is K252562.

When did Spine & Trauma Navigation Instruments receive FDA 510(k) clearance?

Spine & Trauma Navigation Instruments received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252562.

Who is the listed applicant for Spine & Trauma Navigation Instruments?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spine & Trauma Navigation Instruments?

The FDA product code for Spine & Trauma Navigation Instruments is OLO.

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Otros registros que enlistan a Brainlab AG como solicitante

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PAD K243142Cranial 4Pi Immobilization K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)K242569Mixed Reality Spine Navigation

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Fuente oficial

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