
X-Spine Systems, Inc.
Free shipping on orders over $99 · 30-day returns
FORTEX PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K090224) manufactured by X-Spine Systems, 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 29, 2009. Regulation: 8.