510(k) K212083

Tactoset Injectable Bone Substitute by Anika Therapeutics, Inc. — Product Code MQV

K212083 is an FDA 510(k) premarket notification submitted by Anika Therapeutics, Inc. for the device "Tactoset Injectable Bone Substitute". The FDA issued a decision of Substantially Equivalent on August 31, 2021. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Anika Therapeutics, Inc. has at least 8 other 510(k) clearances on record.