Endoskeleton TCS Interbody Fusion Device

Endoskeleton TCS Interbody Fusion Device is an FDA 510(k)-cleared medical device (K191565) manufactured by Titan Spine, 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 August 5, 2019. Regulation: 8.