K251395
- 510(k) number
- K251395
- Device name
- The Rialto SI Fusion System
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-06-26
- Date received
- 2025-05-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251395.pdf
Official FDA record: K251395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.