BIOSPINE VBR SYSTEM

BIOSPINE VBR SYSTEM is an FDA 510(k)-cleared medical device (K110864) manufactured by Aesculap Implant Systems, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 14, 2011. Regulation: 8.