Atlas Spine Expandable Cervical Standalone Interbody System

Atlas Spine Expandable Cervical Standalone Interbody System is an FDA 510(k)-cleared medical device (K192570) 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 February 27, 2020. Regulation: 8.