510(k) K140075

U2 FEMORAL COMPONENT, CR, POROUS COATED by United Orthopedic Corp. — Product Code MBH

K140075 is an FDA 510(k) premarket notification submitted by United Orthopedic Corp. for the device "U2 FEMORAL COMPONENT, CR, POROUS COATED". The FDA issued a decision of Substantially Equivalent on June 13, 2014. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. United Orthopedic Corp. has at least 10 other 510(k) clearances on record.