VERTEX(r) Reconstruction System

VERTEX(r) Reconstruction System is an FDA 510(k)-cleared medical device (K152338) 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 October 27, 2015. Regulation: 8.