ULTIMA AUGMENTED UHMWPE CUP

ULTIMA AUGMENTED UHMWPE CUP is an FDA 510(k)-cleared medical device (K950563) manufactured by Johnson & Johnson Professionals, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 1995. Regulation: 8.