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X-spine spinal systems win FDA clearance

The US Food and Drug Administration (FDA) has cleared X-spine's new spinal systems to treat various spinal pathologies.

The products including Fortex CoCr Rod system incorporates a new cobalt chromium fixation rod, designed to provide increased construct strength, stiffness and shape-holding while performing thoracic and lumbar spine deformity procedures.

The company’s other product, Certex Cervico-thoracic Fixation system, features a comprehensive platform of implants and instruments for cervical stabilization procedures.

X-spine president and CEO David Kirschman said both the spinal systems were developed with intensive practitioner input to address the practical needs of spine surgeons and patients.

"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," Kirschman added.

"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."