K251365
- 510(k) number
- K251365
- Device name
- OptumSI Implant System
- Applicant
- Si Solutions, LLC MO · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-11-20
- Date received
- 2025-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251365.pdf
Official FDA record: K251365
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.