ALPHATEC EXTERNAL FIXATION SYSTEM

ALPHATEC EXTERNAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K964400) manufactured by Alphatec Mfg., 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 April 27, 1997. Regulation: 8.