MAXIMIS SPINAL FIXATION SYSTEM

MAXIMIS SPINAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K140359) manufactured by Valorem Surgical. 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 6, 2015. Regulation: 8.