MODIFICATION TO: ORLUS MINI SCREW

MODIFICATION TO: ORLUS MINI SCREW is an FDA 510(k)-cleared medical device (K052968) manufactured by Ortholution Co., Ltd.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 7, 2006. Regulation: 8.