Stand-Alone ALIF Titanium System

Stand-Alone ALIF Titanium System is an FDA 510(k)-cleared medical device (K191834) manufactured by Life 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 December 15, 2019. Regulation: 8.