510(k) K240046

Ethylene Oxide Sterilization Supplier Change for MPO Hips by Microport Orthopedics — Product Code LPH

K240046 is an FDA 510(k) premarket notification submitted by Microport Orthopedics for the device "Ethylene Oxide Sterilization Supplier Change for MPO Hips". The FDA issued a decision of Substantially Equivalent on April 18, 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. Microport Orthopedics has at least 10 other 510(k) clearances on record.