510(k) K890054

M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. by Protek, Inc. — Product Code JDI

K890054 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.". The FDA issued a decision of SN on February 8, 1989. 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.