510(k) K980926

DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION by Howmedica Corp. — Product Code JDI

K980926 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION". The FDA issued a decision of Substantially Equivalent on December 16, 1998. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Howmedica Corp. has at least 10 other 510(k) clearances on record.