TiWAVE-C™ Porous Titanium Cervical Cage

TiWAVE-C™ Porous Titanium Cervical Cage is an FDA 510(k)-cleared medical device (K180401) manufactured by Kalitec Direct, 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 June 13, 2018. Regulation: 8.