510(k) K230492

Avitus® Precision Autograft Delivery System by Avitus Orthopaedics, Inc. — Product Code FMF

K230492 is an FDA 510(k) premarket notification submitted by Avitus Orthopaedics, Inc. for the device "Avitus® Precision Autograft Delivery System". The FDA issued a decision of Substantially Equivalent on June 26, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Avitus Orthopaedics, Inc. has at least 4 other 510(k) clearances on record.