510(k) K222807

TEMA Elbow system - Line extension by Lima Corporate S.P.A. — Product Code JDB

K222807 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "TEMA Elbow system - Line extension". The FDA issued a decision of Substantially Equivalent on October 26, 2022. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.