Omnia Medical TiBrid-SC— 510(k) K212612

Substantially Equivalent

Omnia Medical, LLC

FDA 510(k) clearance K212612 for Omnia Medical TiBrid-SC, Substantially Equivalent on 2022-11-15. Applicant: Omnia Medical, LLC.

Clearance details

Applicant: Omnia Medical, LLC
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2021-08-17
Decision date: 2022-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgantown,, WV, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.