510(k) K222967

Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws by Avanti Orthopaedics, Inc. — Product Code HWC

K222967 is an FDA 510(k) premarket notification submitted by Avanti Orthopaedics, Inc. for the device "Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws". The FDA issued a decision of Substantially Equivalent on November 23, 2022. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Avanti Orthopaedics, Inc. has at least 3 other 510(k) clearances on record.