ENDOSKELETON(R) TL INTERBODY FUSION DEVICE

ENDOSKELETON(R) TL INTERBODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K140055) manufactured by Titan Spine, 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 July 1, 2014. Regulation: 8.