K241870
- 510(k) number
- K241870
- Device name
- OnPoint Augmented Reality Spine System
- Applicant
- Onpoint Surgical, Inc. MA · US
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2024-08-19
- Date received
- 2024-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241870.pdf
Official FDA record: K241870
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.