OMNI TiN Coated Apex Knee™ System

OMNI TiN Coated Apex Knee™ System is an FDA 510(k)-cleared medical device (K191765) manufactured by Omni Life Science, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2019. Regulation: 8.