The Certex OCT Spinal Fixation System, developed by Xtant Medical unit X-spine Systems, has obtained the CE mark from European regulators. The product is designed to promote fusion in the spine's occipito-cervico-thoracic areas.
The Fortex and the Xpress 2 Pedicle Screw System, developed by Xtant Medical unit X-spine Systems, have been cleared by the FDA for additional indications. The clearance covers the extended-length screws as well as the products' use in ilium fixation. The screws were developed to complement fusion in addressing spinal tumors, kyphosis, scoliosis, dislocation, fracture, previously unsuccessful fusion and degenerative spondylolisthesis.
The Aranax Cervical Plate from Xtant Medical unit X-spine Systems has obtained clearance from the FDA. The product, indicated for patients requiring spinal fusion on one to four adjoining cervical spine levels, is set for a limited release next quarter and a full launch early next year.
The FDA has cleared X-Spine to market its Zygafix Facet Fusion System, which is implanted using a minimally invasive procedure to help stabilize the facet joint. The system adds to the company's Silex and Axle lines of novel spinal-fusion devices.