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Novabone Products, LLC
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NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT is an FDA 510(k)-cleared medical device (K082672) 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 December 8, 2008. Regulation: 8.