HARRINGTON-TYPE INSTRU-SCOLIOSIS

HARRINGTON-TYPE INSTRU-SCOLIOSIS is an FDA 510(k)-cleared medical device (K840423) manufactured by Link America, 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 22, 1984. Regulation: 8.