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510(k) Data Aggregation

    K Number
    K131540
    Device Name
    INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Date Cleared
    2013-09-03

    (97 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTEBRAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterFuse L - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse L device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse L device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
    Device Description
    VTI's InterFuse L - Intervertebral Body Fusion device is made of implant grade Polyetheretherketone (PEEK- OPTIMA®, Grade LT1), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. The device has two modules. Module A has a rail and Module B has a slot. The modules are installed by using VTI's proprietary slot riding the rail technology. Both modules have tantalum beads that aid in visualizing the implanted device under X-ravs. Each module incorporates a ramp lock to help ensure that it is properly aligned and engaged with the other module. Each module has two vertical slots through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in six heights (7 mm, 8 mm, 9 mm, 10 mm, 12 mm and 14 mm) each for parallel and 8 lordotic configurations to fit the angular geometry of the disc at each disc level. Four anterior - posterior (AP) lengths (16 mm, 18 mm, 21 mm and 24 mm) of the device are being offered. The device will be available in 7 Medial - Lateral (ML) dimensions (35 mm, 40 mm, 45 mm, 50 mm, 55 mm 60 mm and 65 mm). VTI will supply a set of Instruments (all non-sterile, re-usable manual instruments) for implantation of InterFuse L by a Direct-Lateral Lumbar Interbody Fusion technique.
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    K Number
    K110226
    Device Name
    INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Date Cleared
    2011-05-27

    (122 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTEBRAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterFuse® T - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
    Device Description
    VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Polyetheretherketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-rav. Each segment has an integral rail and/or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment (B) is installed. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights (8, 10, 12 and 14 mm) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. InterFuse T device will be available in two anterior - posterior (AP) lengths of 20 mm and 24 mm. The middle segment (B) comes in two widths (9 mm or 10 mm).
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    K Number
    K110045
    Device Name
    INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Date Cleared
    2011-02-03

    (28 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTEBRAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterFuse® DA Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). The InterFuse DA device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse DA device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
    Device Description
    The implantable portion of VTI's InterFuse DA interbody fusion device (IFD) is made of implantable grade PEEK (Poly ether ether ketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-ray and to aid in position retention when assembled in the disc space. Each segment has an integral rail and / or slot which slide through or over the rail or slot in the adjacent segment to complete the device (see photos below). Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail, with a stainless steel (Grade 304) tail, of each segment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and six segments for optimum coverage of the vertebral endplate. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights and two anterior-posterior dimensions to fit a range of potential disc spaces. The device will also be produced in flat and angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.
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    K Number
    K102277
    Device Name
    INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Date Cleared
    2010-10-06

    (56 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTEBRAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterFuse® T - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
    Device Description
    VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Poly ether ether ketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-ray. Each segment has an integral rail and/or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment is installed. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights (8, 10, 12 and 14 mm) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. The Anterior - Posterior (AP) length of the device is 24 mm. The middle seament (B) comes in two widths (9 mm or 10 mm).
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    K Number
    K093675
    Device Name
    INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Date Cleared
    2009-12-23

    (26 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTEBRAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterFuse® Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved. spinal level(s). The InterFuse device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
    Device Description
    VTI's Intervertebral Body Fusion device is made of PEEK (Poly ether ether ketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-ray and to aid in position retention when assembled in the disc space. Each segment has an integral rail and/or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a stop to or sior in the unjudent cogment with the adjacent segment. The exposed rail of each segment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and suction's and lew as three segments to be used, annough most politics. Each segment has a vertical slott segments for uptimatir coverage or the vertise and that will provide a path for solid Infough the belice for the Salgeon to mi With Bategis produced in four heights (8, 10, 12 and 14 bone grown during the foston process. " The (2011-11 and 25 mm) and two antenor-posicilion allifensity (is and 5 angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.
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    K Number
    K091988
    Device Name
    MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Date Cleared
    2009-07-30

    (28 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTEBRAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterFuse® Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse device is indicated for use with autogenous bone graft and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
    Device Description
    The implantable portion of VT's IFD device is made of PEEK (Poly ether ether ketone), a polymer with a history of use in interbody fusion devices, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-ray and to aid in position retention when assembled in the disc space. Each segment has an integral rail and / or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail, with a stainless steel tail, of each seqment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and six segments for optimum coverage of the vertebral endplate. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights (8, 10, 12 and 14 mm) and two anterior-posterior dimensions (20 mm and 25 mm) to fit a range of potential disc spaces. The device will also be produced in flat and 5 angled (lordotic) shapes to fit the anqular geometry of the disc at each disc level.
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    K Number
    K080673
    Device Name
    INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Date Cleared
    2008-06-10

    (92 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTEBRAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterFuse™ Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
    Device Description
    VTI's IFD device is made of PEEK, a polymer with a history of use in interbody fusion device designs, and which has modulus similar to bonc. Each segment of the device has embedded metal beads (tantalum) that aid in visualizing the implanted device under x-ray and to aid in position retention when assembled in the disc space. Each segment has an integral rail and / or slot which slides through the rail or slot in the adjacent segment to complete the device. Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail of each segment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and six segments for optimum coverage of the vertebral end plate. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights and two anterior-posterior dimensions to fit a range of potential disc spaces. The device will also be produced in flat and angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.
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