510(k) K200011

E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS by Microport Orthopedics, Inc. — Product Code LPH

K200011 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS". The FDA issued a decision of Substantially Equivalent on October 1, 2021. 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, Inc. has at least 10 other 510(k) clearances on record.