Profile: X-Spine Systems, Inc. manufactures implants and instruments for spinal surgery. Our products include hydratable de-mineralized allograft used for placement in transverse process gutters for postero-lateral fusion, in intervertebral cage, in the intervertebral space to augment structural allograft and for filling of bone voids. We also offer Capless® pedicle screw system for spinal fixation, Fortex™ pedicle screw system, Spider™ cervical plating system and Calix™ cervical interbody spacer. Our Calix™ cervical interbody spacer system is comprised of precision instruments and implants to aid in cervical fusion. Our Capless system technology platform provides solution for the treatment of the thoracic, lumbar and sacral regions of the spine.
FDA Registration Number: 3005031160
18 Products/Services (Click for related suppliers)
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• Allografts |
• Anterior Cervical Plating System |
• Anterior Lumbar Plating Systems |
• Anterior Thoracolumbar Plating System |
• Bone Allografts |
• Capless Pedicle Screw Systems |
• Cervical Allograft Spacer System |
• Cervical Interbody Spacers |
• Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080) |
• Hydratable Demineralized Allografts |
• Pedicle Screw System |
• PEEK Spacer System |
• Posterior Cervical Plating Systems |
• Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ / 888.3060) A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions. |
• Spinal Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070) Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors. |
• Spinal Pedicle Screw Fixation Appliance System (FDA Code: MCV) |
• Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060) |
• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070) |