NuVasive TLX Interbody System

NuVasive TLX Interbody System is an FDA 510(k)-cleared medical device (K171633) manufactured by Nu Vasive, Incorporated. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 2017. Regulation: 8.