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Facet Gun Cleared!
US Spine is pleased to announce that Monday, June 19, 2006, US Spine received FDA approval of the revolutionary Facet Fixation system. This announcement falls on the heels of the widely successful exposure that the Facet Gun received at the recent AANS meeting in San Francisco. This important milestone clears the way for US Spine to begin Beta Site testing of the device at various sites around the country. These Beta Sites will allow US Spine to "put the Facet Gun through it's paces," in a real world environment, and prepare ourselves for the expected National Rollout at the upcoming North American Spine Society meeting in Seattle, WA in September. Congratulations to Dr. Falahee and the entire Facet Gun Team! See the official press release listed below. US Spine Announces Successful FDA Clearance for the Facet Fixation SystemBoca Raton, Florida – June 19, 2006, US Spine, an emerging leader in the development of innovative technologies for the treatment of human spinal disorders, is pleased to announce 510(k) clearance of the Facet Fixation System by the United States Food and Drug Administration. The Facet Fixation System is a less-invasive alternative to pedicle screws as a means of creating a posterior tension band to support an Interbody fusion. The system consists of the Facet Gun, a disposable, pistol-like instrument, and the Facet Bolt, a three-piece implant that consists of a facet screw, a variable angle washer, and a locking nut. Doris Blake, President of US Spine, said, "This is a significant milestone for our company. It's always exciting to witness the evolution of an idea, all the way through to a real product." Dr. Mark Falahee, the inventor of the Facet Fixation System, added, "The Facet Gun makes traditional spinal fusion much easier. The gun allows simple, reliable targeting and placement, by simply pulling the triggers. And the implant is more than just a facet screw, it's a bolt. Bolts are inherently stronger and more rigid, which is perfect for this application." The company is positioning the Facet Fixation System as an alternative to pedicle screw fixation for one and two-level spine fusions, an estimated $600 million dollar segment in the multi-billion dollar spinal implant market. US Spine plans to release the device in 3Q06, at the North American Spine Society annual meeting in Seattle, Washington. US SpineAbout U.S. Spinal Technologies, LLC d/b/a US Spine: US Spine is a privately funded company developing innovative spinal products in collaboration with leading surgeons and scientists. Founder Doris Blake, U.S. Spinal Technologies' President, started the Boca Raton Company in 2004 with the vision of "Advancing the Science of Spine" as it relates to the treatment of degenerative spinal disease. More information is located at http://www.us-spine.com. For more information, contact: |
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Copyright © 2006 US Spine |
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