K251525
- 510(k) number
- K251525
- Device name
- SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- Applicant
- Si-Technology, LLC CO · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-06-06
- Date received
- 2025-05-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K251525.pdf
Official FDA record: K251525
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.