AUGMENT-T POSTERIOR SPINAL SYSTEM

AUGMENT-T POSTERIOR SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K950717) manufactured by Sofamor Danek USA,Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 1996. Regulation: 8.