Opticage(R) Expandable Interbody Fusion Device

Opticage(R) Expandable Interbody Fusion Device is an FDA 510(k)-cleared medical device (K160464) manufactured by Interventional Spine, 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 April 3, 2016. Regulation: 8.