510(k) K173898

MicroPort Orthopedics Total Hip Systems MR Labeling by Microport Orthopedics Inc. (Mpo) — Product Code LZO

K173898 is an FDA 510(k) premarket notification submitted by Microport Orthopedics Inc. (Mpo) for the device "MicroPort Orthopedics Total Hip Systems MR Labeling". The FDA issued a decision of Substantially Equivalent on Sep 20, 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.