ELLIS EXTERNAL MINI-FIXATOR SYSTEM

ELLIS EXTERNAL MINI-FIXATOR SYSTEM is an FDA 510(k)-cleared medical device (K964458) 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 December 8, 1996. Regulation: 8.