NeoFuse Ti3D PLIF/TLIF/Cervical Interbody

NeoFuse Ti3D PLIF/TLIF/Cervical Interbody is an FDA 510(k)-cleared medical device (K170318) manufactured by Ht Medical, 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 11, 2017. Regulation: 8.