FDA 510(k)

The Rialto SI Fusion System

K-Number: K251395 · 2025-06-26

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2025-06-26

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

The Rialto SI Fusion System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2025-06-26 under approval number K251395. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Rialto SI Fusion System?

The Rialto SI Fusion System is a medical device that received FDA 510(k) clearance on 2025-06-26. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K251395.

When was The Rialto SI Fusion System approved by the FDA?

The Rialto SI Fusion System received FDA 510(k) clearance on 2025-06-26, under approval number K251395.

What company makes The Rialto SI Fusion System?

The Rialto SI Fusion System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for The Rialto SI Fusion System?

The FDA product code for The Rialto SI Fusion System is OUR.

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.