ROI-C Titanium-Coated Implant System

ROI-C Titanium-Coated Implant System is an FDA 510(k)-cleared medical device (K151934) manufactured by Ldr Spine USA. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2015. Regulation: 8.