510(k) K181491

Delta Dual Mobility System by Lima Corporate S.P.A. — Product Code LZO

K181491 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "Delta Dual Mobility System". The FDA issued a decision of Substantially Equivalent on May 9, 2019. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Lima Corporate S.P.A. has 63 other 510(k) clearances on record.