CLICK'X MONOAXIAL SCREWS AND HOOKS

CLICK'X MONOAXIAL SCREWS AND HOOKS is an FDA 510(k)-cleared medical device (K031175) 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 November 13, 2003. Regulation: 8.