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FDA 510(k)

Mixed Reality Spine Navigation

K-Number: K242569 · 2025-05-16

ApplicantBrainlab AG
Decision Date2025-05-16
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Mixed Reality Spine Navigation is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2025-05-16 under approval number K242569. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mixed Reality Spine Navigation?

Mixed Reality Spine Navigation is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Brainlab AG. The 510(k) number is K242569.

When was Mixed Reality Spine Navigation approved by the FDA?

Mixed Reality Spine Navigation received FDA 510(k) clearance on 2025-05-16, under approval number K242569.

What company makes Mixed Reality Spine Navigation?

Mixed Reality Spine Navigation is manufactured by Brainlab AG.

What is the FDA product code for Mixed Reality Spine Navigation?

The FDA product code for Mixed Reality Spine Navigation is SBF.

Related Clinical Trials

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Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Brainlab AG

K153653DICOM Viewer K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review K172820Microscope Navigation Software K190250Microscope Navigation K183605Spine & Trauma Navigation

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Related Devices (Code: SBF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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