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The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications: - Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with o degeneration of the disc confirmed by patient history and radiographic studies) - Trauma (including fractures) - o Tumors - Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ● - Pseudoarthrosis ● - Failed previous fusions ● - Spondylolisthesis ● - Spinal Stenosis ●

The Medina Anterior Cervical Plate System (ACP) System is intended for anterior screw fixation to the cervical spine. The Medina ACP system consists of a variety of shapes and sizes of bone plates and screws. The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and commercially pure titanium per ASTM F67. Components of the Medina ACP System should not be used with components from any other system or manufacturer, with exception of the Cage Pins which are to be used only with Alliance Spine's Alamo C or Alamo C-Ti systems. The Medina ACP System components are provided non-sterile. The products need to be steam sterilized by the hospital prior to use.

The Alamo® C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from either PEEK Optima® LT1 per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization or titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the vertebral end plates. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges (teeth) to improve fixation and stability and prevent back out and migration.

The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas.

The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries of malleable low profile cranial plates including straight, box, and gap plates, burr hole covers, malleable mesh as well as fasteners (screws) that provide stable internal fixation of cranial fractures and bone flaps, as well as coverage and stabilization of burr holes and other cranial defects. The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification.

The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications: • Degenerative Disk 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) • Pseudoarthrosis • Failed previous fusions • Spondylolisthesis • Spinal Stenosis

The Nakoma Anterior Cervical Plating (ACP) system is used for spinal fusion surgery to provide support and structural stability. The system consists of a variety of plates and screws, all of which are manufactured from titanium alloy per ASTM F136. Instrumentation necessary for proper implantation is also included. The plates are available in a range of lengths in Levels 1-5 and feature windows to aid in visualization and locking clips to assist in screw retention. The screws are available in multiple lengths and diameters, feature self-tapping and self-drilling designs and are able to be placed on-axis and at various angles (15° medial/lateral, 10° cephalad/caudal).

The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

The Alamo T device is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. Supplemental fixation and autograft is required to facilitate fusion. The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration. The purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.

The Alamo C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from an anterior (ACIF) surgical approach. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The Alamo T is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

The Alamo T is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a transforaminal (TLIF) surgical approach. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The Alamo P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a posterior approach.

The Alamo P is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from a posterior (PLIF) surgical approach. The device is available in various heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.

The SwannShidi Bone Marrow Aspiration Needle consists of a 15ga needle and an angled tip stylet of corresponding size. A depth gauge with graduated scale and additional locking mechanism allows for adjustment of the penetration section of the needle. A luer lock connection is provided to allow aspiration of bone marrow or autologous blood by use of a standard surgical syringe. The SwannShidi is a single use, disposable device that will be supplied sterile.