Omnia Medical Rotary PLIF System

Omnia Medical Rotary PLIF System is an FDA 510(k)-cleared medical device (K183659) 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 February 5, 2019. Regulation: 8.