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The Southern Spine C Fuse™ Cervical Intervertebral Body Fusion System is intended for single level spinal fusion procedures in skeletally mature patients with degenerative disc disease ("DDD") of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The C-Fuse device is to be implanted via an anterior approach at the C3 to C7 disk levels using autogenous bone graft and is to be combined with supplemental fixation. Patients should have had at least six weeks of non-operative treatment prior to treatment with the device.

The C.Fuse Cervical Intervertebral Body Fusion System is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an adjunct to spinal fixation. The device is trapezoidal in shape, with machined grooves on the superior and inferior surfaces, along with a hollow center core to accept autogenous bone graft. There are two materials used in the manufacture of the Southern Spine C-Fuse Cervical Intervertebral Body Fusion System devices which are the Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560. There is instrumentation for implantation and a sterilization trav for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.

The StabiLink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); tumor. It is not intended for stand-alone use.

The Stabilink™ MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion. The system is implanted via a posterior approach to the spine. The StabiLink™ MIS Spinal Fixation System includes various sizes of Titanium plate constructs. There is instrumentation for implantation and a sterilization tray for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.

The Southern Spine Anterior Cervical Stabilization System (SSACSS) is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine (C2-T1) during the development of cervical spine fusions in patients with degeneration 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. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Southern Spine Anterior Cervical Stabilization System (SSACSS) is used as a temporary construct that assists in normal healing and is not intended to replace normal body structures. The system is implanted via an anterior approach to the cervical spine. The SSACSS includes various sizes of Titanium plates with or without Tissue Shields that may be used for One-Level, Two-Level, and Three-Level anterior cervical fusion procedures. There is a selection of Titanium screws and instrumentation for implantation. The implants and delivery instrumentation are provided Non-Sterile.