ACE OPEN-BACK HALO RING

ACE OPEN-BACK HALO RING is an FDA 510(k)-cleared medical device (K914858) manufactured by Ace Medical Co.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 1991. Regulation: 8.