K251395

Substantially Equivalent

The Rialto SI Fusion System

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: OUR
Advisory panel: Orthopedic
Date received: 2025-05-05
Decision date: 2025-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.