510(k) K213563

DePuy Synthes Radial Head Replacement System by DePuy Synthes — Product Code KWI

K213563 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes Radial Head Replacement System". The FDA issued a decision of Substantially Equivalent on March 18, 2022. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. DePuy Synthes has at least 10 other 510(k) clearances on record.