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The VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components, The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping, self drilling or rigid cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a rigid cervical screw.

The VERTEBRON PSS™ Pedicle Screw System is intended for non-cervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The modified VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spine and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks and locking caps. This submission adds Curved Rods and Screw Spacers.

The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.

The VERTEBRON Interbody Fusion System consists of various heights, angles and configurations (i.e., square, rectangular D-shaped, etc.). The device is use singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy. The VERTEBRON Interbody Fusion System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM 2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. The VERTEBRON Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F560) are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The material used is PEEK ASTM F2026-07e1 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy (TI-6AI-4V) that conforms to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The VERTEBRON PSSIM Pedicle Screw System is intended for noncervical, nonpedicte fixation for the following indications: degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicte fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VERTEBRON PSS Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 5.5, 6.5 & 7.5mm Cannulated MA Screws & Buttress Cap.

The Modified VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical soins fue tempor patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic shudies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordnois, ar scoliosis), pseudoarthriosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.

The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 4.5mm Standard and MA Screws.

The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks and locking caps. This submission adds both adjustable and fixed cross connectors.

The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The material used is medical grade titanium material that conforms to ASTM F136.

The Vertebron SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

The device consists of a system of implantable metal plates and screws intended the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.