ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)

ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) is an FDA 510(k)-cleared medical device (K083714) 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 April 14, 2009. Regulation: 8.