NOVEL VBR SPINAL SYSTEM

NOVEL VBR SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K042201) manufactured by Alphatec/Nexmed. 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 6, 2004. Regulation: 8.