510(k) K160907

DePuy Actis DuoFix Hip Prosthesis by Depuy(Ireland) — Product Code MEH

K160907 is an FDA 510(k) premarket notification submitted by Depuy(Ireland) for the device "DePuy Actis DuoFix Hip Prosthesis". The FDA issued a decision of Substantially Equivalent on July 19, 2016. 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. Depuy(Ireland) has at least 10 other 510(k) clearances on record.