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Home » X-Spine wins FDA clearance for spinal fusion system

X-Spine wins FDA clearance for spinal fusion system

May 16, 2013 By Sony Salzman

X-Spine

X-Spine Systems won an FDA nod for its Zygafix facet fusion system, which stabilizes the facet joint using a hollow titanium compression screw and internal bone graft. The device is approved for patients who have failed traditional non-surgical treatments.

The Miamisburg, Ohio-based company is touting the device as an improvement over the Fixcet, which uses a solid titanium compression screw.

"Facet systems are continuing to gain in popularity as a less-invasive alternative to pedicle screws for posterior spinal stabilization," said CEO David Kirschman in a company release. "The Zygafix system is unique in that it allows for both direct bone grafting and mechanical screw fixation of the facet joint within a single implant through a minimally invasive approach."

In 2012, the company landed 2 FDA nods for its Fortex CoCr Rod System and the Certex Cervico-thoracic Fixation System.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Spine Tagged With: X-spine Systems Inc.

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