K230857
- 510(k) number
- K230857
- Device name
- TiLink-P SI Joint Fusion System
- Applicant
- SurGenTec, LLC FL · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2023-09-25
- Date received
- 2023-03-29
- 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: K230857.pdf
Official FDA record: K230857
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.