510(k) K163193

UTF Stem, reduced, #0, #00 by United Orthopedic Corporation — Product Code LPH

K163193 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "UTF Stem, reduced, #0, #00". The FDA issued a decision of Substantially Equivalent on Jun 8, 2017. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. United Orthopedic Corporation has 40 other 510(k) clearances on record.