510(k) K870922

C.L.E. ACETABULAR CUP by Protek, Inc. — Product Code JDI

K870922 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "C.L.E. ACETABULAR CUP". The FDA issued a decision of Substantially Equivalent on October 28, 1987. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Protek, Inc. has at least 10 other 510(k) clearances on record.