K250001
- 510(k) number
- K250001
- Device name
- Patriot SI Implant System
- Applicant
- Spinal Simplicity, LLC KS · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-06-03
- Date received
- 2025-01-02
- 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: K250001.pdf
Official FDA record: K250001
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.