TiWAVE-L Porous Titanium Lumbar Cage

TiWAVE-L Porous Titanium Lumbar Cage is an FDA 510(k)-cleared medical device (K182210) manufactured by Kalitec 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 January 6, 2019. Regulation: 8.