X-Spine lands FDA approval for two spinal implants

X-spine Systems Inc. has received FDA approval for two spinal implants, advancing the company as a full-line spinal system provider.X-spine Systems Inc. has received FDA approval for two spinal implants, advancing the company as a full-line spinal system provider.The Miamisburg-based company, which manufactures spinal implants and instruments for use in spinal surgery, gained federal approval for its Fortex CoCr Rod System and Certex Cervico-thoracic Fixation System.
The Fortex CoCr adds strength and functionality to the original Fortex system with a cobalt chromium fixation rod, and the Certex system expands X-spine’s product offerings into the posterior cervical spine, according to the company.
“It is our strategy to be able to address every instrumented spinal pathology and approach with our products, while leading with innovative design and surgical practicality,” said Dr. David Kirschman, president and CEO. “These two clearances exemplify this strategy and represent the beginning of a new product initiative at X-spine, which will see five major product introductions in the next year.”
Within the past few years, X-spine has received approval for eight other spinal devices.
Source:Laura Englehart Staff Reporter- Dayton Business Journal