ULTIMA UNIPOLAR MODULAR HEAD

ULTIMA UNIPOLAR MODULAR HEAD is an FDA 510(k)-cleared medical device (K940190) manufactured by Johnson & Johnson Orthopaedics, 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 September 28, 1994. Regulation: 8.