K252088
- 510(k) number
- K252088
- Device name
- Firebird SI Navigation System
- Applicant
- Orthofix US, LLC TX · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-10-31
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252088.pdf
Official FDA record: K252088
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.