K260477
- 510(k) number
- K260477
- Device name
- CATAMARAN SI Joint Fusion System
- Applicant
- Tenon Medical CA · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2026-04-08
- Date received
- 2026-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260477.pdf
Official FDA record: K260477
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.