OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM

OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM is an FDA 510(k)-cleared medical device (K140978) manufactured by Osteomed. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 2014. Regulation: 8.