510(k) K960302

CONSENSUS ACETABULAR SHELL, ALL UHMWPE by U.S. Medical Products, Inc. — Product Code JDI

K960302 is an FDA 510(k) premarket notification submitted by U.S. Medical Products, Inc. for the device "CONSENSUS ACETABULAR SHELL, ALL UHMWPE". The FDA issued a decision of Substantially Equivalent on April 1, 1996. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. U.S. Medical Products, Inc. has at least 10 other 510(k) clearances on record.