GIZA(R) VERTEBRAL BODY REPLACEMENT

GIZA(R) VERTEBRAL BODY REPLACEMENT is an FDA 510(k)-cleared medical device (K112429) manufactured by Eden 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 January 25, 2012. Regulation: 8.