510(k) K231968

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

K231968 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 December 20, 2023. 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 10 other 510(k) clearances on record.