NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE

NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE is an FDA 510(k)-cleared medical device (K021336) 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 July 24, 2002. Regulation: 8.