K213590

Substantially Equivalent

Blue Topaz Sacroiliac Screw System

Applicant: Osseus Fusion Systems, LLC
Product code: OUR
Advisory panel: Orthopedic
Date received: 2021-11-12
Decision date: 2022-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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.