OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM

OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM is an FDA 510(k)-cleared medical device (K063792) manufactured by Osteomed LP. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 1, 2007. Regulation: 8.