510(k) K152071

NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) by Novabone Products, LLC — Product Code MQV

K152071 is an FDA 510(k) premarket notification submitted by Novabone Products, LLC for the device "NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)". The FDA issued a decision of Substantially Equivalent on August 26, 2015. 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.