510(k) K191622

Delta Multihole TT Pro Acetabular System by Lima Corporate S.P.A. — Product Code LPH

K191622 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "Delta Multihole TT Pro Acetabular System". The FDA issued a decision of Substantially Equivalent on Nov 1, 2019. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Lima Corporate S.P.A. has 63 other 510(k) clearances on record.