510(k) K974685

OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS by Osteonics Corp. — Product Code JDI

K974685 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS". The FDA issued a decision of Substantially Equivalent on September 22, 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. Osteonics Corp. has at least 10 other 510(k) clearances on record.