Curiteva Porous PEEK Cervical Interbody Fusion System

Curiteva Porous PEEK Cervical Interbody Fusion System is an FDA 510(k)-cleared medical device (K254061) manufactured by Curiteva, Inc.. 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 14, 2026. Regulation: 8.