SPECTRON POLYETHYLENE ACCTUBULAR COMPON

SPECTRON POLYETHYLENE ACCTUBULAR COMPON is an FDA 510(k)-cleared medical device (K823728) 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 January 20, 1983. Regulation: 8.