Search Results
Found 340 results
510(k) Data Aggregation
(186 days)
Ask a specific question about this device
(29 days)
Ask a specific question about this device
(183 days)
Ask a specific question about this device
(134 days)
Ask a specific question about this device
(117 days)
Ask a specific question about this device
(108 days)
MSFX Mikron Cervical PEEK Cages are made to be implanted into the appropriate vertebral section to help provide stability for spinal fusion after a diseased cervical disc producing neck and/or arm pain is removed during spinal decompression for patients who have had six weeks of non-operative treatment. Cervical PEEK Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level(C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical PEEK Cages facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and implanted with auto graft/autologous bone graft. They are to be used with supplemental fixation.
MSFX Mikron Lumbar PEEK Cages are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/ autologous bone graft to facilitate fusion for each spinal region.
The MSFX Mikron Peek Cages are intervertebral body fusion devices to be implanted into appropriate cervical and lumbar spine. MSFX Mikron Peek Cages are composed of:
- MSFX Mikron Cervical Peek Cages
- MSFX Mikron Lumbar Peek Cages
MSFX Mikron Cervical Peek cages are designed to maintain the height of the intervertebral space. It is used in surgical procedures where two or more vertebrae are connected or fused together to achieve fusion in spinal disorders. It supports bone fusion and is available in different shapes and sizes. The cage body is made from PEEK (ASTM F2026), and the pin, marker and screws are produced from Ti6Al4V ELI (ASTM F136). They are to be used with supplemental fixation, placed via anterior approach and implanted with autograft/autologous bone graft.
MSFX Mikron Lumbar Peek cages are designed to maintain the height of the intervertebral space. It is used in surgical procedures where two or more vertebrae are connected or fused together to achieve fusion in spinal disorders. It supports bone fusion and is available in different shapes and sizes. The cage body is made from PEEK (ASTM F2026), and the pin, marker and expansion mechanism are produced from Ti6Al4V ELI (ASTM F136). The devices are designed to be used with supplemental fixation and autograft/ autologous bone graft to facilitate fusion for each spinal region.
N/A
Ask a specific question about this device
(267 days)
The SPINELINC Anterior Cervical Implants include cervical interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SPINELINC Cervical Spacer Body and Anterior Cervical Spaver are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The SPINELINC Cervical Spacer Body and Anterior Cervical Spacer are intended to be used with FDA cleared supplemental fixation. Only the SPINELINC Cervical Spacer Body is compatible with the SPINELINC Plates and Screws. When used with the SPINELINC Plate and Screws, the plate-spacer assembly takes on the indications for use of the SPINELINC Cervical Spacer Body, with the SPINELINC Plate and Screws acting as the supplemental fixation. The SPINELINC Plate and Cervical Spacer Body assembly is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with three SpineLinc screws per assembly.
The SpineLinc Anterior Cervical Implant system consists of a cervical interbody fusion device, cervical plate, screws, and a locking clip, which may be implanted in various configurations to accommodate patient anatomy. The SpineLinc Anterior Cervical implant devices are offered manufactured from titanium alloy per ASTM F136 or ASTM F3001. Instrumentation is provided with the SpineLinc Anterior Cervical Implant system to facilitate implantation. Instruments are manufactured from medical grade stainless steel per ASTM F899. All subject implants and instruments are provided sterile via gamma irradiation and are provided as single use kits.
N/A
Ask a specific question about this device
(256 days)
The Dakota LP Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Dakota LP Anterior Cervical Interbody Fusion System implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.
The Dakota LP Anterior Cervical Interbody Fusion System includes cervical interbody fusion spacers to provide mechanical support of the cervical spine until fusion of the treated level occurs. The Dakota LP Anterior Cervical Interbody Fusion System implants are offered in a variety of sizes to accommodate patient anatomical needs and are manufactured from Ti-6Al-4V ELI per ASTM F3001 (cages) and Magnolia PEEK per ASTM F2026 with Tantalum per ASTM F560 (cages) with or without commercially pure titanium coating per ASTM F67.
N/A
Ask a specific question about this device
(87 days)
EFFORTMED CERVICAL PEEK CAGES are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. CERVICAL PEEK CAGES facilitate intervertebral body fusion in the cervical spine and are placed via the anterior approach and packed with autograft/autologous bone graft. Patients should have received at least six (6) months of prior non-operative treatment. EFFORTMED CERVICAL PEEK CAGES are to be used with supplemental fixation.
The EFFORTMED LUMBAR PEEK CAGES are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment. The devices are designed to be used with supplemental fixation and autograft/autologous bone graft to facilitate fusion for each spinal region.
The EFFORTMED ORIZABA CERVICAL CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The EFFORTMED COTOPAXI LUMBAR CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The ORIZABA and COTOPAXI CORPECTOMY CAGES are 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
ORIZABA and COTOPAXI CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.
The EffortMed spinal interbody cage system includes cervical intervertebral body fusion (IBFD), transforaminal lumbar interbody fusion (TLIF), and posterior lateral interbody fusion (PLIF) devices. The cervical cage models are the EffortMed Pacaya Cervical PEEK Cage and Masaya Augmented Cervical PEEK cage. The lumbar cage models are the EffortMed TLIF PEEK Cage, Effortmed TLIF PEEK Cage 4° Angled, Effortmed PLIF PEEK Cage, EffortMed PLIF PEEK Cage 5° Angled, and EffortMed Expandable PLIF PEEK Cage. The system was designed to restore height and lordotic angle in the spine. The main role of the cages is to help maintain the cleared disc space stable and intact, until a healthy bony fusion occurs between the adjoining vertebrae. To help achieve this, the inner chamber of the cage body is filled with bone graft before implantation.
The system also includes cervical and corpectomy cages (identified as used in cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to, tumors, fractures, and infections. The corpectomy cage models are the EffortMed Orizaba Cervical Corpectomy cage and EffortMed Cotopaxi Lumbar Corpectomy cage.
N/A
Ask a specific question about this device
(269 days)
BEE HA cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.
The subject BEE HA cage is an anterior cervical interbody fusion device. BEE HA cage is manufactured from PEEK-OPTIMA™ HA Enhanced. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Additionally, the device contains four (4) titanium alloy (Ti6Al4V per ASTM F136) pins to provide imaging visibility for device positioning.
BEE HA cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form.
BEE HA cage is intended for single use only and is provided sterile, using gamma irradiation.
The purpose of this traditional 510k is to expand the size range offerings for the previously cleared BEE HA.
N/A
Ask a specific question about this device
Page 1 of 34