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FDA 510(k)

RIALTO(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) Systems

K-Number: K161210 · 2016-08-12

ApplicantMedtronic Sofamor Danek
Decision Date2016-08-12
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIALTO(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) Systems is a medical device manufactured by Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2016-08-12 under approval number K161210. 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 RIALTO(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) Systems?

RIALTO(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) Systems is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Medtronic Sofamor Danek. The 510(k) number is K161210.

When was RIALTO(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) Systems approved by the FDA?

RIALTO(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) Systems received FDA 510(k) clearance on 2016-08-12, under approval number K161210.

What company makes RIALTO(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) Systems?

RIALTO(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) Systems is manufactured by Medtronic Sofamor Danek.

What is the FDA product code for RIALTO(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) Systems?

The FDA product code for RIALTO(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) Systems is OUR.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Medtronic Sofamor Danek

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View all 9 devices →

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.

Official Source

View on FDA Database →

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

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