510(k) K182670

FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute by Prosidyan, Inc. — Product Code MQV

K182670 is an FDA 510(k) premarket notification submitted by Prosidyan, Inc. for the device "FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute". The FDA issued a decision of Substantially Equivalent on December 20, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Prosidyan, Inc. has at least 10 other 510(k) clearances on record.