K242569
- 510(k) number
- K242569
- Device name
- Mixed Reality Spine Navigation
- Applicant
- Brainlab AG DE
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-05-16
- Date received
- 2024-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K242569.pdf
Official FDA record: K242569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.