BIOCERAMIC ORBITAL IMPLANT, ORBTEX

BIOCERAMIC ORBITAL IMPLANT, ORBTEX is an FDA 510(k)-cleared medical device (K110554) manufactured by Ceramisys, Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2011. Regulation: 8.