OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM

OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM is an FDA 510(k)-cleared medical device (K031708) 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 November 2, 2003. Regulation: 8.