510(k) K142675

CI../..X liner for NOVAE Dual Mobility Acetabular Cup by Serf — Product Code LZO

K142675 is an FDA 510(k) premarket notification submitted by Serf for the device "CI../..X liner for NOVAE Dual Mobility Acetabular Cup". The FDA issued a decision of Substantially Equivalent on January 15, 2015. 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. Serf has at least 3 other 510(k) clearances on record.