510(k) K161210— 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

Substantially Equivalent

Medtronic Sofamor Danek

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2016-04-28
Decision date: 2016-08-12
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.