APEX KNEE MODULAR TIBIA SYSTEM

APEX KNEE MODULAR TIBIA SYSTEM is an FDA 510(k)-cleared medical device (K131472) 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 October 7, 2013. Regulation: 8.