SpineFab Vertebral Body Replacement (VBR) System

SpineFab Vertebral Body Replacement (VBR) System is an FDA 510(k)-cleared medical device (K142005) manufactured by Oxford Performance Materials. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 9, 2015. Regulation: 8.