AVAFLEX VERTEBRAL AUGMENTATION NEEDLE

AVAFLEX VERTEBRAL AUGMENTATION NEEDLE is an FDA 510(k)-cleared medical device (K072133) manufactured by Cardinal Health, 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 November 19, 2007. Regulation: 8.