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510(k) Data Aggregation
K Number
K151406Device Name
Cogent Lateral Interbody System
Manufacturer
COGENT SPINE LLC
Date Cleared
2016-02-25
(275 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
COGENT SPINE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cogent Lateral Interbody System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Device Description
The Cogent Lateral Interbody System is an intervertebral body fusion device intended to stabilize the spinal segment to promote fusion. The implants are available in a variety of lengths and heights to accommodate varying patient anatomy. The Cogent Lateral Interbody System implants and instruments are supplied non-sterile. The implants in the The Cogent Lateral Interbody System are manufactured from PEEK, Ti-6Al-4V, and tantalum.
The Cogent Lateral Interbody consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers.
The Cogent Lateral Interbody is available in various sizes to accommodate varying patient anatomy. The Cogent Lateral Interbody System is 18 or 22mm wide and includes five available lengths, 40, 45, 50, 55, and 60mm. The Cogent Lateral Interbody System is also available in three lordotic options, 0°, 6°, and 12°. The Cogent Lateral Interbody System is available in heights of 8mm to 16mm.
The Cogent Lateral Interbody System implants may be inserted via an open or minimally invasive approach and may be placed in a lateral or anterolateral orientation.
The Cogent Lateral Interbody System implants are non-sterile and are to be sterilized by the end user.
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K Number
K142193Device Name
COGENT MED-LIF XL
Manufacturer
COGENT SPINE LLC
Date Cleared
2014-10-15
(65 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
COGENT SPINE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cogent Mcd-LIF XL is indicated for use with autogenous bone graft 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 I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Device Description
The Cogent Med-LIF XL includes additional sizes to the Cogent Med-LIF system. The Cogent Med-LIF XL is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF XL consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular antimigration teeth, and tantalum x-ray markers.
The Cogent Med-LIF XL is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options. 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 15mm wide and are available in three lengths; 28, 30 and 32mm.
The Cogent Med-LIF XL implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space.
The Cogent Med-LIF XL implants are non-sterile and are to be sterilized by the end user.
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K Number
K132738Device Name
COGENT MED-LIF
Manufacturer
COGENT SPINE LLC
Date Cleared
2014-04-15
(224 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
COGENT SPINE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cogent Med-LIF is indicated for use with autogenous bone graft 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 I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
Device Description
The Cogent Med-LIF is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers. The Cogent Med-LIF is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options, 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 10mm wide and are available in three lengths; 20, 25 and 30mm. The Cogent Med-LIF implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space. The Cogent Med-LIF implants are non-sterile and are to be sterilized by the end user.
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