K253604
- 510(k) number
- K253604
- Device name
- TiLink-L Navigation Instruments
- Applicant
- SurGenTec, LLC FL · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-03-20
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K253604.pdf
Official FDA record: K253604
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.