510(k) K190890

Exactech Alteon Modular Dual Mobility (MDM) System by Exactech, Inc. — Product Code LZO

K190890 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "Exactech Alteon Modular Dual Mobility (MDM) System". The FDA issued a decision of Substantially Equivalent on October 22, 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. Exactech, Inc. has at least 10 other 510(k) clearances on record.