K251639
- 510(k) number
- K251639
- Device name
- xvision Spine system
- Applicant
- Augmedics, Ltd. IL
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-10-03
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251639.pdf
Official FDA record: K251639
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.