510(k) K904870

MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON by Endotec, Inc. — Product Code KXA

K904870 is an FDA 510(k) premarket notification submitted by Endotec, Inc. for the device "MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON". The FDA issued a decision of Substantially Equivalent on May 23, 1991. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Endotec, Inc. has at least 10 other 510(k) clearances on record.