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The EOI FLXfit™ 15 and FLXfit™ Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The EOI FLXfit™ 15 and FLXfit™ devices are intended to be used with supplemental spinal fixation system and with autogenous bone graft. Important: FLXfit™ 15 must be applied in combination with posterior fusion system such as the EOI Spinal System.

EOI FLXfit15 Intervertebral Body Fusion Device is made from titanium (Ti6Al4V-ELI per ASTM F136). This is an articulated-expanded device with height ranges from 8mm through 13mm. The device also expands in height to provide lordosis angle correction of up to 15°.

The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The EOI FLXfit device is intended to be used with supplemental spinal fixation system and with autogenous bone graft.

EOI FLXfit Intervertebral Body Fusion Device is made From Titanium (Ti6A14V-ELI per ASTM norm F136). This is an articulated-expanded device with height ranges from 8mm through 14mm. The device also expands in height to provide lordosis angle correction of up to 10°. The FLXfit components are manufactured from titanium alloy (ASTM F136). It is implanted via a Transforaminal approach and supplemented by posterior fixation. The device is made from two titanium segments that are serrated on the superior and inferior surfaces. The titanium segments are attached (linked) with titanium wedge pins that provide the means to form the implant into its final articulated shape.

The EOI Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to spinal fusion of the thoracic, lumbar, and/or sacral spine. The EOI Spinal System is limited to non-cervical, pedicle use and is specifically indicated for treatment of one or more of the following acute and chronic instabilities or deformities: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (fracture or dislocation); 4. Deformities or curvatures (scoliosis, kyphosis, and/or lordosis); 5. Tumor; 6. Spinal stenosis; 7. Pseudoarthrosis; and/or 8. Failed previous fusion.

The EOI Spinal System consists of polyaxial pedicle screws in varying diameters and lengths, Ø5.5mm straight and pre-bent rods in varying lengths, and cross connectors in adjustable widths to build a spinal construct. EOI Spinal System components are manufactured from implant grade titanium alloy [Ti-6Al-4V ELI] in accordance with ASTM F-136. Instrumentation is also available to facilitate implantation of the device components. The EOI Spinal System can be rigidly locked into a variety of configurations suitable to the patient's unique anatomy. Implant components and instrumentation are provided non-sterily and must be sterilized prior to use. As with all orthopedic implants, all implant components in this system are single-use and should never be reused.