510(k) K240621

Morpheus® Moldable; Agilon® Moldable by Biogennix, LLC — Product Code MQV

K240621 is an FDA 510(k) premarket notification submitted by Biogennix, LLC for the device "Morpheus® Moldable; Agilon® Moldable". The FDA issued a decision of Substantially Equivalent on April 30, 2024. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Biogennix, LLC has at least 8 other 510(k) clearances on record.