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The SpineView X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

The Spine View X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the transforaminal approach. The device is available in various sizes to accommodate varying anatomy. The primary difference between the previously cleared and the modified cage models is that the expansion of the upper plate is parallel to the bottom housing, whereas the previously cleared device expands at an angle. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136 and ASTM F1295. The Spine View X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before use.

The SpineView X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

The SpineView X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a caqe implant and instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the transforaminal approach. The device is available in various sizes to accommodate varying anatomy and can expand to the desired lordosis. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136 and ASTM F1295. The SpineView X-Pac Expandable Lumbar Cage System implants are singleuse, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The instruments are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before use.

The FlexLite™ Camera is indicated for use for endoscopic visualization in the surgical area of the cervical, thoracic, or lumbar spine during diagnostic or interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

The Spine View FlexLite™ Camera is a flexible, reusable arthroscope designed for endoscopic visualization during diagnostic or interventional spinal procedures with access to the target area established through a surgical opening. The device includes fiber-optic illumination bundles with an integrated LED light source in the handle and a distal tip CCD image sensor with associated electronics. The camera is offered to support NTSC and PAL video formats. The FlexLite™ Camera is designed for use with the commercially available Vision-Sciences DPU-5050 Video Processor Unit (K102733, K072073) for image display and transfer. The FlexLite™ Camera contains neither software nor firmware. The FlexLite™ Camera is provided non-sterile to the customer and must be cleaned and sterilized by the user prior to each use.

The Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

The Minimally Invasive Surgical (MIS) Decompression System is a collection of arthroscopic surgical accessories provided sterile (irradiated) and intended for single-use only. As a group, the accessories are provided to facilitate delivery of an endoscope and other instruments to the targeted treatment site. The addition of a new accessory, the enCise Bone Cutter, as an additional surgical tool to facilitate removal of soft and hard (bone) tissue during interventional spinal procedures. The new component will be offered in two configurations: one compatible with flexible endoscopes, and the second compatible with rigid endoscopes. Two additional enVue Cannula models are also being introduced for compatibility with rigid endoscopes: Long and Standard Jaw. Introduction of the new enCise Bone Cutter and additional configurations of the already cleared enVue Cannula do not affect the intended use or alter the fundamental scientific technology of the system. The additional accessories being proposed in the modified MIS Decompression System are listed below: - . enCise Bone Cutter: a tubular sheath with a mechanical "chisel" tip feature designed to cut soft and hard (cartilaginous, bone) tissue during spinal procedures. The enCise Bone Cutter is offered in two configurations (one compatible with flexible endoscopes, and the second compatible with rigid endoscopes). - enVue Cannula, Standard and Long Jaw: configurations for use with rigid . endoscopes. The working end of the accessories is identical to the previously cleared enVue Cannulas. The only difference is in the handle, which is modified to accommodate rigid endoscopes (up to 5.9 mm OD; 205 mm working length).

The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectorny procedures in the cervical, thoracic and lumbar spine.

The modified enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber. The modified enSpire™ Discectorny System is supplied as a sterile, single patient use, disposable device.

Surgical accessories are indicated for facilitating endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

The SpineVu Endoscopic Spine System (SESS) is a collection of arthroscopic surgical accessories provided sterile (irradiated) and intended for single-use only. As a group, the accessories are provided to facilitate delivery of an endoscope and other instruments to the targeted treatment site. The SpineVu Endoscopic Spine System (SESS) consists of the following devices: enVue Cannula, enVue Sheath, 16G Introducer Cannula with Stylet, Guidewire, Dilator, Beveled Cannula, Ball-Tipped Probe, Infusion Cannula, Suction Cannula.

The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

The enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber. The enSpire™ Discectomy System is supplied as a sterile, single patient use, disposable device.

The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

The SpineView ENSPIRE™ Debrider is a single-use discectomy device that is designed to cut and grind intervertebral disc material. Its auger mechaeo mechaeo um retrieves the excised debris and ejects it into a collection chamber.

The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

The SESS kit is a collection of arthroscopic surgical accessories, including a bipolar RF electrosurgical accessory. The Spine Vu MiniScope is an arthroscope.