X-spine Announces New FDA Clearance Of Spinal Implant System

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 06 May 2009 - 1:00 PDT

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X-spine, an emerging manufacturer of implants and instruments for spinal surgery, announces FDA clearance of its new Calix spinal implant system. The system is designed to function as a cervical intervertebral fixation device as well as a vertebral body replacement device in the thoracic and lumbar spine. The Calix system is manufactured from PEEK-Optima polymer, which enjoys widespread adoption in spinal surgery due to its excellent mechanical and biological properties. The system is X-spine's sixth FDA-cleared spinal product. "We are excited about the Calix because it represents our first product to address cervical interbody fixation," states Dr. David Kirschman, X-spine CEO. "X-spine has earned tremendous growth in the anterior cervical plating market with our Spider Cervical plating system, so the addition of an interbody product to pair with it represents a great opportunity for us." X-spine will introduce the product at the American Association of Neurological Surgeons meeting in San Diego, CA on the 5th of May.

X-spine is an emerging leader in the development and manufacture of novel technologies for the treatment of spinal disease. Based in Ohio, privately-held X-spine markets spinal implants and surgical instruments worldwide for the treatment of spinal degenerative disease, deformity, trauma, and spinal tumors.

Source
X-spine

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