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The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.

The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. The subject submission introduces additional designs and sizes of the arch screw and locking screw. - Arch Screw will be implanted in patient's bone then autograft will be inserted. - Locking Screw can be used with washer or can be used on its own - Self-tapping flute centers screw for easy insertion

The Paeon Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with: - degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), - spondylolisthesis. - trauma (i.e. fractures or dislocations), - tumors, - deformity (defined as kyphosis, lordosis, or scoliosis), - pseudoarthrosis, - failed previous fusion, - spinal stenosis. The Elatus Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an aqunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

The Paeon Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile. The Elatus Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The Elatus Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.

ABTross ALIF Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. ABTross ALIF Expandable Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>=20° lordosis) must be used with at least anterior supplemental fixation.

The ABTross ALIF Expandable Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.

The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The Paeon Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (TI-T3): traumatic spinal fractures and or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Paeon Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Paeon Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with: - · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), - · spondylolisthesis, - · trauma (i.e. fractures or dislocations), - · tumors, - · deformity (defined as kyphosis, lordosis, or scoliosis), - · pseudoarthrosis, - · failed previous fusion, - · spinal stenosis. The Spinema Lumbar Plate System is indicated for use via the anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spinal stenosis, or a failed previous spine surgery.

The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. - Arch Screw will be implanted in patient's bone then autograft will be inserted. . - Locking Screw can be used with washer or can be used on its own ● - Self-tapping flute centers screw for easy insertion . Posterior Cervical Fixation System is a top-loading, multiple components, The Paeon posterior (cervical-thoracic) spinal fixation system which consists of polyscrew, Reduction poly screw, partially screw, semi-reduction partially screw, straight rod, curved rod, set screw, hooks and accessories that can be used via an open surgical approach. The devices are manufactured from titanium alloy per ASTM F136 and cobalt chromium per ASTM F1537. The Paeon Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, fourlevel fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile. The Spinema Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The Spinema Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55

XYPAN Expandable Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. XYPAN Expandable Lumbar Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The XYPAN Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation. - -XYPAN-XT Expandable Cage is to be implanted via transforaminal and posterior approach. - -XYPAN-XTP Expandable Cage is to be implanted via Anterior to Psoas approach. - XYPAN-XL Expandable Cage is to be implanted via lateral approach. -