TRAUMAFIX (TM) EXTERNAL FIXATOR

TRAUMAFIX (TM) EXTERNAL FIXATOR is an FDA 510(k)-cleared medical device (K914558) manufactured by Synthes (Usa). 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, 1992. Regulation: 8.