510(k) K260173

M-Vizion Femoral Revision System Extension by Medacta International S.A. — Product Code LZO

K260173 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "M-Vizion Femoral Revision System Extension". The FDA issued a decision of Substantially Equivalent on September 17, 2026. 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. Medacta International S.A. has at least 10 other 510(k) clearances on record.