510(k) K140946

NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE by Novabone Products, LLC — Product Code MQV

K140946 is an FDA 510(k) premarket notification submitted by Novabone Products, LLC for the device "NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE". The FDA issued a decision of Substantially Equivalent on August 22, 2014. 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.