510(k) K223745

Novae® Dual Mobility System, Hype® Hip System by Serf — Product Code LZO

K223745 is an FDA 510(k) premarket notification submitted by Serf for the device "Novae® Dual Mobility System, Hype® Hip System". The FDA issued a decision of Substantially Equivalent on December 22, 2023. 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.