ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT

ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT is an FDA 510(k)-cleared medical device (K142052) manufactured by Orthofix Srl. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2014. Regulation: 8.