ORTHOFIX AXIALEXTERNAL FIXATION SYS.

ORTHOFIX AXIALEXTERNAL FIXATION SYS. is an FDA 510(k)-cleared medical device (K802814) manufactured by Cintor Orthopaedic Div.. 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 9, 1980. Regulation: 8.