FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT is an FDA 510(k)-cleared medical device (K023400) manufactured by Fci Ophthalmics, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2003. Regulation: 8.