510(k) K181744

BI-MENTUM dual mobility system by Serf — Product Code LZO

K181744 is an FDA 510(k) premarket notification submitted by Serf for the device "BI-MENTUM dual mobility system". The FDA issued a decision of Substantially Equivalent on December 11, 2018. 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.