NORMED MANDIBULAR FIXATION SYSTEM

NORMED MANDIBULAR FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K010118) manufactured by Osteomedics, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2001. Regulation: 8.