Endoskeleton TO Interbody Fusion Device (IBD)

Endoskeleton TO Interbody Fusion Device (IBD) is an FDA 510(k)-cleared medical device (K170399) 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 5, 2017. Regulation: 8.