GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW

GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW is an FDA 510(k)-cleared medical device (K083567) manufactured by Co-Ligne AG. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2009. Regulation: 8.