NOVABONE POROUS-BONE GRAFT SCAFFOLD

NOVABONE POROUS-BONE GRAFT SCAFFOLD is an FDA 510(k)-cleared medical device (K060432) 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 3, 2006. Regulation: 8.