510(k) K192352

MiniMAX by Medacta International S.A. — Product Code LZO

K192352 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MiniMAX". The FDA issued a decision of Substantially Equivalent on Sep 27, 2019. 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 207 other 510(k) clearances on record.