K251943
- 510(k) number
- K251943
- Device name
- Spineology Navigation Instruments
- Applicant
- Spineology, Inc. MN · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-12-04
- Date received
- 2025-06-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251943.pdf
Official FDA record: K251943
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.