Anjon Bremer Halo System

Anjon Bremer Halo System is an FDA 510(k)-cleared medical device (K193256) manufactured by Anjon Holdings, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 1, 2020. Regulation: 8.