510(k) K220216

C-Stem AMT LE Prosthesis by Depuy Ireland UC — Product Code JDI

K220216 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "C-Stem AMT LE Prosthesis". The FDA issued a decision of Substantially Equivalent on July 22, 2022. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Depuy Ireland UC has at least 10 other 510(k) clearances on record.