510(k) K213342

PRO-DENSE LoVisc Bone Graft Substitute by Wrightmedicaltechnologyinc — Product Code MQV

K213342 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "PRO-DENSE LoVisc Bone Graft Substitute". The FDA issued a decision of Substantially Equivalent on January 5, 2022. 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.