SI-FIX SACROILIAC JOINT FUSION SYSTEM— 510(k) K110472

Substantially Equivalent

Medtronic Sofamor Danek

FDA 510(k) clearance K110472 for SI-FIX SACROILIAC JOINT FUSION SYSTEM, Substantially Equivalent on 2012-05-29. Applicant: Medtronic Sofamor Danek.

Clearance details

Applicant: Medtronic Sofamor Danek
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2011-02-18
Decision date: 2012-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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.