Class Class II
The Rialto™ SI Fusion System (K251395)
Description
The Rialto™ SI Fusion System by Medtronic Sofamor Danek USA, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251395
Clearance Date2025-06-26
Clearance TypeTraditional
Product CodeOUR
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251395
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. The Rialto™ SI Fusion System (K251395) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments... | Medtronic Sofamor Danek | 2016 |
Trace the full predicate network for K251395
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.