AXIA RADIAL HEAD SYSTEM

AXIA RADIAL HEAD SYSTEM is an FDA 510(k)-cleared medical device (K132735) manufactured by Imds (Innovative MEdical Device Systems) - Leis ME. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2014. Regulation: 8.