510(k) K211657

EMPHASYS Femoral Stems by Depuy Ireland UC — Product Code LZO

K211657 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "EMPHASYS Femoral Stems". The FDA issued a decision of Substantially Equivalent on Aug 5, 2021. 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. Depuy Ireland UC has 49 other 510(k) clearances on record.