510(k) K901240

ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED by Med-Tek Corp. — Product Code JDI

K901240 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED". The FDA issued a decision of Substantially Equivalent on March 26, 1990. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Med-Tek Corp. has at least 10 other 510(k) clearances on record.