Ortus™ Expandable Lumbar Interbody Fusion System

Ortus™ Expandable Lumbar Interbody Fusion System is an FDA 510(k)-cleared medical device (K172334) manufactured by Atlas 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 October 24, 2017. Regulation: 8.