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The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the non-cervical spine for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiosraphic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The eCarbon rods can be used in the treatment of the above indications for use with the exception of procedures requiring instrumentation that spans more than 3-levels.

The Dymaxeon Spine System is a posterior pedicle screw system designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of a variety of pedicle screws, rods, hooks, connectors and fasteners. The implants are sold sterile.

The eCarbon-C is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The eCarbon-C is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one level or two contiguous levels from C2 - T1. The eCarbon-C is to be used with supplemental fixation. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. The eCarbon-P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, the eCarbon-P can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The eCarbon-P is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

The eCarbon IBDs are a collection of interbody devices. The cervical implants (eCarbon-C) have basic keystone shape in a columnar form while the lumbar devices (eCarbon-P) are essentially rectangular. All have a central cavity for bone graft and are offered in a variety of height, length, width and lordotic angulation combinations are available to accommodate the anatomic requirements of individual patients.

The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6A14V per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of a variety of pedicle screws, rods, hooks, and connectors. The Dymaxeon Spine System can be used for single or multiple level fixations. The purpose of this submission is to obtain clearance for a modification to the tulip and mating set screws.

The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, soliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of polyaxial pedicle screws and rods. The Dymaxeon Spine System can be used for single or multiple level fixations. The additional Ø5.5mm rod, cannulated screw, transverse connector, and hook components will be used in conjunction with the predicate Dymaxeon Spine System during the fixation of the spine. The components are manufactured from titanium alloy and come in a variety of lengths.