K252170
- 510(k) number
- K252170
- Device name
- OptiVu Shoulder
- Applicant
- Mr Surgical Solutions, LLC PA · US
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-08-08
- Date received
- 2025-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252170.pdf
Official FDA record: K252170
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.