Omnia Medical TiBrid™-SA System

Omnia Medical TiBrid™-SA System is an FDA 510(k)-cleared medical device (K240623) manufactured by Omnia Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 23, 2024. Regulation: 8.