BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC is an FDA 510(k)-cleared medical device (K140844) manufactured by Synergy Biomedical, 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 July 15, 2014. Regulation: 8.