C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM is an FDA 510(k)-cleared medical device (K130948) manufactured by Southern Spine, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2013. Regulation: 8.