510(k) K191764

Inion BioRestore by Inion OY — Product Code MQV

K191764 is an FDA 510(k) premarket notification submitted by Inion OY for the device "Inion BioRestore". The FDA issued a decision of Substantially Equivalent on July 31, 2019. 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.