510(k) K212933

INHANCETM Hybrid Anatomic Glenoid Implant by Depuy Ireland UC — Product Code MBF

K212933 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "INHANCETM Hybrid Anatomic Glenoid Implant". The FDA issued a decision of Substantially Equivalent on June 8, 2022. 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.