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The Integra Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

The Integra Laminoplasty System consists of titanium alloy plates and screws that are attached to the lamina after a laminoplasty procedure. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage

SeaSpine Spacer System – Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation. Cambria NanoMetalene: Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system. Vu aPOD-L NanoMetalene: The Integra Vu aPOD-L Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease is defined as back pain of discogenic origin, with desc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. Vu ePOD NanoMetalene: When used as an intervertebral body fusion device the Vu ePOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The SeaSpine Spacer System (Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene), Cambria NanoMetalene, Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene devices are intervertebral fusion devices made from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6Al-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to add a 1 micrometer surface of titanium (per ASTM F67) to the exterior surface of each of these devices.

The Integra® Expandable Intervertebral Body Fusion Device (IBD) System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASTM F2026), titanium (Ti-6Al-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiographic tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft. They are available in a range of sizes, and their heights can be intra-operatively expanded to the desired height to accommodate variations in surgical approach and patient anatomy. Non-expandable implants are manufactured from PEEK-OPTIMA® LT1 only with radiopaque markers. The system also includes instruments to assist with the surgical procedure/ implantation, as well as trays and caddies for organization.

Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: - 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 tumor The device is not intended for stand-alone use.

The Integra Spinous Process System consists of an implantable spacer featuring plates of varying lengths with fixed hub diameters and set screws in order to clamp bilaterally to the spinous processes. It is a multicomponent device consisting of two plates coupled by a central hub and locked by a set screw. Each plate contains spikes for fixation to the spinous process to aid in resisting rotation after implantation. The device is available in a range of sizes to accommodate variations in patient pathology and anatomy. It is manufactured from Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and is single use only. The complete system, including insertion and accessory instrumentation for implantation, is packaged in a tray for transportation, cleaning and sterilization.

The Integra® Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) after laminoplasty procedures. The Integra "Laminoplasty System is used to hold the allograft material in place in order to prevent the allograft material from expulsion, or impinging the spinal cord.

The Integra® Laminoplasty System consists of plates and screws that are attached to the lamina after a laminoplasty procedure; the system is manufactured from Titanium 6Al-4V ELI per ASTM F136. Implants are available in a range of sizes and shapes, as well as in various screw hole configurations to accommodate variations in patient anatomy. The system also includes instruments to assist with implantation, and a tray for organization and storage

The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: - degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, - severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System), - trauma (i.e., fracture or dislocation), - spinal stenosis, · - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - tumor, - pseudarthosis, and/or - failed previous fusion. The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows: - degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, - spondylolisthesis, - trauma (i.e., fracture or dislocation), - spinal stenosis. - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - tumor, - pseudarthosis, and/or - failed previous fusion.

The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System.

This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: - degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; - trauma (including fracture or dislocation); - spinal stenosis; - cervical myelopathy; - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); - tumor: - pseudoarthrosis; and/or - failed previous fusion

The Cardiff™ Anterior Cervical Plate (ACP) System is interior interbody screw fixation of the cervical spine only. The Cardiff™ ACP System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The Cardiff™ ACP System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Cardiff™ ACP System implants are manufactured from Titanium and Nitinol alloys. Fixation is provided by bone screws into the vertebral body of the cervical spine using an anterior approach.

The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine.

The SeaSpine Monopolar Probes conduct electrical stimulation to nervous tissue that may be present in close proximity of the surgical corridor to the spine. This system is not comprised of a nerve stimulator or recorder; instead it will use conventional stimulators found in the market. The SeaSpine Monopolar Probes are insulated by a biocompatible PEEK (polyetheretherketone) layer all around one or more conductive stainless steel wire(s) with the exception of the distal and proximal ends. The distal end contacts the target tissue and the proximal end connects to standard intraoperative neuromonitoring monopolar stimulator) that offers triggered electromyography (EMG) capability. Triggered EMG is a standard intraoperative practice where motor nerves are stimulated and their corresponding muscle group response is recorded, allowing for avoidance of nervous tissue during surgical approach. The proximal connector design meets the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.

When used as an intervertebral body fusion device, the Seaser System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation. When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the device is intended for use with bone graft.

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