510(k) K243839

Alteon® HA Femoral Stems by Exactech, Inc. — Product Code MEH

K243839 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "Alteon® HA Femoral Stems". The FDA issued a decision of Substantially Equivalent on March 10, 2025. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Exactech, Inc. has at least 10 other 510(k) clearances on record.