510(k) K230011

Mpact Extension by Medacta International S.A. — Product Code LPH

K230011 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Mpact Extension". The FDA issued a decision of Substantially Equivalent on September 20, 2023. 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. Medacta International S.A. has at least 10 other 510(k) clearances on record.