BREMER HALO SYSTEM TITANIUM SKULL PIN

BREMER HALO SYSTEM TITANIUM SKULL PIN is an FDA 510(k)-cleared medical device (K993099) manufactured by Depuyacromed. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 1999. Regulation: 8.