510(k) K242375

OR3O Dual Mobility System by Smith & Nephew, Inc. — Product Code LPH

K242375 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "OR3O Dual Mobility System". The FDA issued a decision of Substantially Equivalent on October 7, 2024. 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. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.