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The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is interior fixation to the cervical spine C2-C7. The specific clinical indications include: - degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for IMPEACE-UNI and one, two, three, and four level procedures for IMPEACE. Main plate is available from 13mm to 46mm for IMPEACE-UNI and 10mm to 112mm for IMPEACE. Screws are available in lengths from 12mm to 20mm for IMPEACE-UNI and 10mm to 20mm in 2mm increments for IMPEACE. The screws have either a 4.5mm or 5.1mm diameter for IMPEACE-UNI and 4.0mm or 4.5mm diameter for IMPEACE. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.

The Medynus IVA (ACIF) PEEK Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. The Medynis IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S 1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Medynus IVA (ACIF, PLIF, TLIF, DLIF and ALIF) PEEK Cage is intended for intervertebral body fusion in skeletally mature patients. The intended operation of these devices are concentrated around disc levels from the C2-C3 to the C7-T1 for the cervical spine, and from L2 to S1 for the lumbar spine. All the devices are non-sterile, single use - cages of multiple footprints, heights and lordosis options to fit the anatomical needs of a wide variety of patients and are made from PEEK and Tantalum. They have anti-migration features on the superior and inferior surfaces and can be packed with autograft to facilitate fusion.

The Goblin and Goblin LS Pedicle Screw Systems are intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion 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 and pseudarthrosis

The Goblin and Goblin LS Pedicle Screw Systems are top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms. The implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136. Various sizes of these implants are available.