C-BOX PEEK CERVICAL IBF

C-BOX PEEK CERVICAL IBF is an FDA 510(k)-cleared medical device (K132991) manufactured by Innovasis, 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 February 11, 2014. Regulation: 8.