LDR Spine ROI-C Cervical Cage System

LDR Spine ROI-C Cervical Cage System is an FDA 510(k)-cleared medical device (K150765) 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 September 16, 2015. Regulation: 8.