Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device

Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device is an FDA 510(k)-cleared medical device (K200002) manufactured by 4Web, 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 May 28, 2020. Regulation: 8.