DOLPHIX EXTERNAL FIXATION SYSTEM

DOLPHIX EXTERNAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K132363) manufactured by Citieffe S.R.L.. 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 15, 2014. Regulation: 8.