510(k) K161233

OXINIUM DH Fermoral Heads by Smith & Nephew, Inc. — Product Code MBL

K161233 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "OXINIUM DH Fermoral Heads". The FDA issued a decision of Substantially Equivalent on December 14, 2016. The device falls under product code MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous), a Class II device regulated under 21 CFR 888.3358. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.