AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G

AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G is an FDA 510(k)-cleared medical device (K131820) manufactured by Care Fusion. 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 3, 2013. Regulation: 8.