510(k) K261145

Avanti Distal Elbow ORIF System by Avanti Orthopaedics, LLC — Product Code HRS

K261145 is an FDA 510(k) premarket notification submitted by Avanti Orthopaedics, LLC for the device "Avanti Distal Elbow ORIF System". The FDA issued a decision of Substantially Equivalent on May 9, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Avanti Orthopaedics, LLC has at least 3 other 510(k) clearances on record.