510(k) K925883

OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS by Osteonics Corp. — Product Code JDJ

K925883 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS". The FDA issued a decision of Substantially Equivalent on June 15, 1993. The device falls under product code JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis), a Class II device regulated under 21 CFR 878.3300. Osteonics Corp. has at least 10 other 510(k) clearances on record.