510(k) K221675

United U2 femoral head, 22mm delta ceramic head by United Orthopedic Corporation — Product Code LPH

K221675 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "United U2 femoral head, 22mm delta ceramic head". The FDA issued a decision of Substantially Equivalent on November 4, 2022. 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 at least 10 other 510(k) clearances on record.