510(k) K230831

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid by Depuy Ireland UC — Product Code MBF

K230831 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid". The FDA issued a decision of Substantially Equivalent on November 13, 2023. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Depuy Ireland UC has at least 10 other 510(k) clearances on record.