NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT

NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT is an FDA 510(k)-cleared medical device (K110368) 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 April 13, 2011. Regulation: 8.