510(k) K250848

Identity Shoulder System by Zimmer, Inc. — Product Code MBF

K250848 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Identity Shoulder System". The FDA issued a decision of Substantially Equivalent on July 2, 2025. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Zimmer, Inc. has at least 10 other 510(k) clearances on record.