Endeavor™ Stand-Alone Cervical IBF System

Endeavor™ Stand-Alone Cervical IBF System is an FDA 510(k)-cleared medical device (K250076) manufactured by Innovasis. 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 24, 2025. Regulation: 8.