SPECTRON NECK REPLACEMENT PROSTHESIS

SPECTRON NECK REPLACEMENT PROSTHESIS is an FDA 510(k)-cleared medical device (K823724) manufactured by Richard'S Medical Equip., 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 March 8, 1983. Regulation: 8.