510(k) K980286

ULTIMA ACETABULAR ROOF REINFORCEMENT RING by Johnson & Johnson Professionals, Inc. — Product Code JDI

K980286 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "ULTIMA ACETABULAR ROOF REINFORCEMENT RING". The FDA issued a decision of Substantially Equivalent on April 3, 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. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.