K243835
- 510(k) number
- K243835
- Device name
- TiLink-P SI Joint Fusion System
- Applicant
- SurGenTec, LLC FL · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2024-12-27
- Date received
- 2024-12-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K243835.pdf
Official FDA record: K243835
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.