BONE INJECTION GUN (B.I.G.)

BONE INJECTION GUN (B.I.G.) is an FDA 510(k)-cleared medical device (K062940) manufactured by Waismed, Ltd.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2006. Regulation: 8.