510(k) K023085

RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM by Biomet Orthopedics, Inc. — Product Code JDI

K023085 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on October 17, 2002. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Biomet Orthopedics, Inc. has at least 10 other 510(k) clearances on record.