510(k) K221809

DePuy Synthes 3.5mm Intrapelvic Acetabular System by DePuy Synthes — Product Code HRS

K221809 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes 3.5mm Intrapelvic Acetabular System". The FDA issued a decision of Substantially Equivalent on September 20, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. DePuy Synthes has at least 10 other 510(k) clearances on record.