T2 STRATOSPHERE™ Expandable Corpectomy System

T2 STRATOSPHERE™ Expandable Corpectomy System is an FDA 510(k)-cleared medical device (K181328) manufactured by Medtronic Sofamor Danek USA, 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 September 18, 2018. Regulation: 8.