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B2b Spine Pty, Ltd.
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DYMAXEON SPINE SYSTEM is an FDA 510(k)-cleared medical device (K121786) manufactured by B2b Spine Pty, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2012. Regulation: 8.