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EffortMed Spinal Fixation System is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non- pedicle fixation system, the EffortMed Spinal Fixation System is intended to provide additional support during fusion using autograft in skeletally mature patients in the following acute and chronic instabilities or deformities: • Degenerative disc disease (DDD) (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 When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EffortMed Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the EffortMed Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis,fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The EffortMed Spinal Fixation System is intended to be used with autograft and/or allograft.

EffortMed Spinal Fixation System is a top-loading, multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (Straight and curved) , connectors , hooks and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136. Various sizes of these components are available.

The ARENAL Anterior Cervical Plate System is intended for fixation and temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions with the following indications: - 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 - Deformities or curvatures (including kyphosis, lordosis, or scoliosis) - Pseudarthrosis - Spondylolisthesis - Spinal stenosis

The ARENAL Anterior Cervical Plate System is interior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral spine with self-tapping or self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation.