NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT

NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT is an FDA 510(k)-cleared medical device (K080009) manufactured by Novabone Products, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 2008. Regulation: 8.