K250167
- 510(k) number
- K250167
- Device name
- Evolution Spine Navigation Instruments
- Applicant
- Evolution Spine TX · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-08-18
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250167.pdf
Official FDA record: K250167
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.