K203207

Substantially Equivalent

Omnia Medical TiBrid-SA

Applicant: Omnia Medical, LLC
Product code: OVD
Advisory panel: Orthopedic
Date received: 2020-10-30
Decision date: 2020-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgantown,, WV, US

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.