K250403
- 510(k) number
- K250403
- Device name
- Catamaran SI Joint Fusion System
- Applicant
- Tenon Medical CA · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-03-21
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250403.pdf
Official FDA record: K250403
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.