510(k) K231526

CORAIL Cemented Femoral Stem by Depuy Ireland UC — Product Code KWY

K231526 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "CORAIL Cemented Femoral Stem". The FDA issued a decision of Substantially Equivalent on December 19, 2023. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Depuy Ireland UC has at least 10 other 510(k) clearances on record.