FDA clears the Fortex CoCr Rod System and the Certex Cervico-thoracic Fixation System

87

The US Food and Drug Administration (FDA) has given clearance to X-spine for two spinal systems: the Fortex CoCr Rod System and the Certex Cervico-thoracic Fixation System.

The Fortex CoCr system incorporates a new cobalt chromium fixation rod which allows for increased construct strength, stiffness and shape-holding. This provides additional functionality to the current Fortex platform of products for the fixation of the thoracic and lumbar spine, particularly in deformity procedures.

The new Certex system expands X-spine’s product offering into the posterior cervical spine, and features a comprehensive platform of implants and instruments for cervical stabilisation procedures.

“Both the Fortex CoCr and the Certex were developed with intensive practitioner input to address the practical needs of spine surgeons and patients worldwide. 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 David Kirschman, president and CEO of X-spine. “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.”

(Visited 18 times, 1 visits today)