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The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. The system implants are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures or dislocation), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Spinal Innovations SPECTRUM™ Cervical Spinal System is intended for anterior intervertebral body screw fixation of the cervical spine. This system includes plates in varying designs and both fixed angle and variable angle screws. The screws are available in diameters of 4.0 mm and 4.5 mm and varying lengths. The plates have two widths: Standard width of .750 inches and Narrow width of .680 inches. The plates will be available in two lordotic curve geometries. The Cervical Screws are cancellous bone screws. The screw locking means is assembled to the plate during the manufacturing process.

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum. The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System are intended for sacral/iliac attachment only. Hooks of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Spinal Innovations Ascend™ Spinal Fixation System with the Shadow™ Spinal System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic. Iumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes fixed and polyaxial screws of varying diameters and lengths, and hooks in varying designs in varying designs and lengths. The Shadow™ components are product line additions to complement the Ascend™ system components.