510(k) K182823

PRODENSE Bone Graft Substitute by Wrightmedicaltechnologyinc — Product Code MQV

K182823 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PRODENSE Bone Graft Substitute". The FDA issued a decision of Substantially Equivalent on November 2, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.