PYLON INTRAMEDULLAARY NAIL SYSTEM

PYLON INTRAMEDULLAARY NAIL SYSTEM is an FDA 510(k)-cleared medical device (K992350) 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 September 21, 1999. Regulation: 8.