510(k) K233712

PRIMA Humeral System; PRIMA TT Glenoid by Lima Corporate S.P.A. — Product Code MBF

K233712 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "PRIMA Humeral System; PRIMA TT Glenoid". The FDA issued a decision of Substantially Equivalent on January 11, 2024. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.