IN:C2 SPINAL FIXATION SYSTME

IN:C2 SPINAL FIXATION SYSTME is an FDA 510(k)-cleared medical device (K141537) manufactured by Spine Smith Holdings, LLC. 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 24, 2014. Regulation: 8.