B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)

B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) is an FDA 510(k)-cleared medical device (K032358) manufactured by Disc-O-Tech Medical Technologies, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 2003. Regulation: 8.