K262121
- 510(k) number
- K262121
- Device name
- Ion-L Navigated Instruments
- Applicant
- SurGenTec, LLC FL · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-07-24
- Date received
- 2026-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K262121.pdf
Official FDA record: K262121
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.