510(k) K090177

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE by Inion OY — Product Code MQV

K090177 is an FDA 510(k) premarket notification submitted by Inion OY for the device "INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on February 20, 2009. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Inion OY has at least 10 other 510(k) clearances on record.