510(k) K101860

NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT by Novabone Products, LLC — Product Code MQV

K101860 is an FDA 510(k) premarket notification submitted by Novabone Products, LLC for the device "NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT". The FDA issued a decision of Substantially Equivalent on September 1, 2010. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Novabone Products, LLC has at least 10 other 510(k) clearances on record.