Endoskeleton(r) TCS System

Endoskeleton(r) TCS System is an FDA 510(k)-cleared medical device (K153122) 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 December 13, 2015. Regulation: 8.