Omnia Medical TiBrid-SA— 510(k) K203207

Substantially Equivalent

Omnia Medical, LLC

FDA 510(k) clearance K203207 for Omnia Medical TiBrid-SA, Substantially Equivalent on 2020-12-23. Applicant: Omnia Medical, LLC.

Clearance details

Applicant: Omnia Medical, LLC
Product code: 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

Download summary PDF View on FDA.gov ↗

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.