510(k) K152439

U2 Bipolar Implant and 22mm Femoral Head by United Orthopedic Corporation — Product Code KWY

K152439 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "U2 Bipolar Implant and 22mm Femoral Head". The FDA issued a decision of Substantially Equivalent on April 7, 2016. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.