FLXFIT INTERVERTEBRAL BODY FUSION DEVICE

FLXFIT INTERVERTEBRAL BODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K133813) manufactured by Expanding Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 2014. Regulation: 8.