Search Results

The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

The PediGuard System is a hand held, battery operated bi-polar probe that is comprised of the following components: (1) a stainless steel shaft; (2) a hollow plastic handle; and (3) an electronic cartridge. Its components are manufactured from stainless steel and plastics according to ASTM and USP requirements.

The Spacevision™ Cage System is intended for use as partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body in the thoracolumbar spine (T1-L5). The Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.

The Spacevision cage implant is an oval shaped device with teeth on the upper and lower portions. The implant is hollow and can be used with bone graft when implanted. The implant is manufactured from PEEK Optima® LT1 and contains tantalum beads for location on radiographs. A variety of sizes are available, and the implants may be inserted individually or in pairs.

The Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who: - have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - receive fusions using autogenous bone graft only; - have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and - have the device removed after the development of a solid fusion. In addition, the Uni-Thread 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 neurologic impairment - fracture - dislocation - scoliosis - kyphosis - spinal tumor - failed previous fusion (pseudoarthrosis)

The Uni-Threaad Spinal System instrumentation consists of screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The Uni-Thread System components are available in titanium alloy manufactured according to ASTM-F136.

When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for: - degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - spondylolisthesis - fracture - spinal stenosis - deformities (i.e. scoliosis, kyphosis, lordosis) - tumors - failed previous fusion (pseudoarthrosis) The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who: - have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - receive fusions using autogenous bone graft only; - have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and - have the device removed after the development of a solid fusion. In addition, the PLUS Pivot Link Universal 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 neurologic impairment - fracture - dislocation - scoliosis - kyphosis - spinal tumor - failed previous fusion (pseudoarthrosis)

The PI.US Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and The 11100 Proceed be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.

When used for anterior screw fixation or as a posterior, non-pedicle system of the nohcervical spine, the PLUS™ Pivot Link Universal System is indicated for: - degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history . and radiographic studies) - spondylolisthesis . - fracture ● - spinal stenosis ◆ - deformities (i.e. scoliosis, kyphosis, lordosis) ● - tumors - failed previous fusion (pseudoarthrosis) . The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who: - . have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - receive fusions using autogenous bone graft only; - have the device fixed or attached to the lumbar and sacral spine (L3 to ● sacrum); and - . have the device removed after the development of a solid fusion. In addition, the PLUS Pivot Link Universal 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 neurologic impairment - fracture . - dislocation ● - scoliosis - kyphosis ● - . spinal tumor - failed previous fusion (pseudoarthrosis) .

The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.

When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for: - degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history and radiographic studies) - spondylolisthesis . - fracture ● - spinal stenosis ● - deformities (i.e. scoliosis, kyphosis, lordosis) ● - tumors - failed previous fusion (pseudoarthrosis) ● The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who: - have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - receive fusions using autogenous bone graft only; - have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and ● - have the device removed after the development of a solid fusion. . In addition, the PLUS Pivot Link Universal 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 neurologic impairment - fracture ● - dislocation . - scoliosis ● - . kyphosis - spinal tumor - failed previous fusion (pseudoarthrosis) ●

The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.

The UNI-T Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who: - have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; . - receive fusions using autogenous bone graft only; . - · have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and - have the device removed after the development of a solid fusion. . In addition, the UNI-T Uni-Thread Spinal System is a pedicle screw system intended to provide In addition, the UNF-1 Unl-Tiread Spinal System is a pkelers on on adjunct to fusion in fusion in fusion in immobilization and Sabilization of Spiralis in Skolouny Industry Industry of the thoracic, lumbar, and sacral spine: - Degenerative spondylolisthesis with objective evidence of neurologic impairment . - fracture ◆ - . dislocation - scoliosis . - kyphosis . - spinal tumor . - failed previous fusion (pseudoarthrosis) .

The UNI-T Uni-Thread Spinal System instrumentation consists of screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The UNI-T System components are available in titanium alloy, manufactured according to ASTM F136.

When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for: - degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - spondylolisthesis - fracture - spinal stenosis - deformities (i.e. scoliosis, kyphosis, lordosis) - tumors - failed previous fusion (pseudoarthrosis) The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who: - have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; - receive fusions using autogenous bone graft only; - have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and - have the device removed after the development of a solid fusion. In addition, the PLUS Pivot Link Universal 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 neurologic impairment - fracture - dislocation - scoliosis - kyphosis - spinal tumor - failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel, manufactured according to ASTMs F138 and F1586.