K251780
- 510(k) number
- K251780
- Device name
- iGPS Navigation Instruments
- Applicant
- SI-BONE, Inc. CA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-09-15
- Date received
- 2025-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251780.pdf
Official FDA record: K251780
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.