ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD

ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD is an FDA 510(k)-cleared medical device (K993873) 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 January 2, 2000. Regulation: 8.