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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 the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-05-16 under 510(k) 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. The listed applicant is Brainlab AG. The 510(k) number is K242569.

When did Mixed Reality Spine Navigation receive FDA 510(k) clearance?

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

Who is the listed applicant for Mixed Reality Spine Navigation?

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 Mixed Reality Spine Navigation?

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05891002Accuracy of Robotically Assisted Cranial BiopsiesTERMINATEDNCT07737886Feasibility, Acceptability, and Preliminary Effects of Virtual Reality for Pain, Anxiety and Recovery Enhancement of Children Post-scoliosis Surgical RepairNOT_YET_RECRUITING

Other records listing Brainlab AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutK252562Spine & Trauma Navigation InstrumentsK243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADK243142Cranial 4Pi ImmobilizationK250440RT 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 RTK243633Brainlab 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)

View all 52 devices →

Related Devices (Code: SBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261854xvision Spine systemAugmedics, Ltd.K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLC

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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