K261381
- 510(k) number
- K261381
- Device name
- TiLink-L SI Joint Fusion System
- Applicant
- SurGenTec, LLC FL · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2026-08-24
- Date received
- 2026-04-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261381.pdf
Official FDA record: K261381
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.