EXPANDABLE PEEK VBR IMPLANT

EXPANDABLE PEEK VBR IMPLANT is an FDA 510(k)-cleared medical device (K040928) manufactured by Interpore Cross Intl.. 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 26, 2004. Regulation: 8.