510(k) K150862

DePuy Actis Duofox Hip Prosthesis by DePuy Orthopaedics, Inc. — Product Code MEH

K150862 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DePuy Actis Duofox Hip Prosthesis". The FDA issued a decision of Substantially Equivalent on September 25, 2015. 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 Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.