NADIA SI Fusion System— 510(k) K190580

Substantially Equivalent

Ilion Medical, Inc.

FDA 510(k) clearance K190580 for NADIA SI Fusion System, Substantially Equivalent on 2020-08-05. Applicant: Ilion Medical, Inc..

Clearance details

Applicant: Ilion Medical, Inc.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2019-03-06
Decision date: 2020-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.