K261854
- 510(k) number
- K261854
- Device name
- xvision Spine system
- Applicant
- Augmedics, Ltd. IL
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2026-07-31
- Date received
- 2026-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K261854.pdf
Official FDA record: K261854
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.