Elite Expandable Interbody Fusion Device

Elite Expandable Interbody Fusion Device is an FDA 510(k)-cleared medical device (K162879) manufactured by Spineology, 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 29, 2017. Regulation: 8.