510(k) K191074

Sorrento Bone Graft Substitute by Xenco Medical, LLC — Product Code MQV

K191074 is an FDA 510(k) premarket notification submitted by Xenco Medical, LLC for the device "Sorrento Bone Graft Substitute". The FDA issued a decision of Substantially Equivalent on September 27, 2019. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Xenco Medical, LLC has at least 10 other 510(k) clearances on record.