
Spine Next America Corporation
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FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 is an FDA 510(k)-cleared medical device (K042714) manufactured by Spine Next America Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 2004. Regulation: 8.