K250108
- 510(k) number
- K250108
- Device name
- OptiVu Shoulder
- Applicant
- Mr Surgical Solutions, LLC PA · US
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-07-09
- Date received
- 2025-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K250108.pdf
Official FDA record: K250108
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.