Captiva Spine FuselOX Cervical IBF System

Captiva Spine FuselOX Cervical IBF System is an FDA 510(k)-cleared medical device (K142586) manufactured by Captiva Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 27, 2015. Regulation: 8.