ANTERIOR KYPHOSIS DISTRACTION DEVICE

ANTERIOR KYPHOSIS DISTRACTION DEVICE is an FDA 510(k)-cleared medical device (K802222) manufactured by Zimmer, 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 October 9, 1980. Regulation: 8.