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510(k) Data Aggregation

    K Number
    K152568
    Device Name
    C-VBR
    Manufacturer
    CARDINAL SPINE, LLC
    Date Cleared
    2016-02-11

    (155 days)

    Product Code
    PLR
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDINAL SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C-VBR is a vertebral body replacement device indicated for use in the cervical spine (spanning C2-T1 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The C- VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The C-VBR System is 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
    Device Description
    C-VBR is a vertebral body replacement device manufactured from titanium alloy (Ti-6AI-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. C-VBR is a single-piece device manufactured using electrical discharge machining. having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach. C-VBR is to be used in combination with supplemental fixation indicated for use in the cervical spine. C-VBR is provided with superior and inferior endplates that are either parallel (no lordosis) or angled to provide intrinsic lordosis (9.6° or 11.5°), and with various heights from 16 mm to 72 mm.
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    K Number
    K142030
    Device Name
    STGC-LORDOTIC
    Manufacturer
    CARDINAL SPINE, LLC
    Date Cleared
    2015-01-23

    (182 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDINAL SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.
    Device Description
    STGC-Lordotic is a vertebral body replacement device manufactured from titanium allov (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. STGC-Lordotic is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach, STGC-Lordotic is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine. STGC-Lordotic is provided with 8.2° to 11.5° of endplate angulation (lordosis). STGC-Lordotic is provided non-sterile to the end user.
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    K Number
    K121176
    Device Name
    STGC
    Manufacturer
    CARDINAL SPINE, LLC
    Date Cleared
    2012-08-17

    (121 days)

    Product Code
    MQP, CLA
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDINAL SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STGC is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The STGC is intended to be used with autograft or allograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.
    Device Description
    The STGC is a vertebral body replacement device manufactured from titanium alloy (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. The STGC is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allografi bone. Intended for placement via an anterior approach, the STGC is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine.
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    K Number
    K100698
    Device Name
    STCC
    Manufacturer
    CARDINAL SPINE, LLC
    Date Cleared
    2011-03-14

    (368 days)

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

    CARDINAL SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STCC is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) 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 anterior approach and used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
    Device Description
    STCC is an implantable intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V) and is available in a variety of different sizes to suit the individual anatomic and clinical circumstances of each patient. Intended for placement via an anterior approach, the device has a trapezoidal cross section with a hollow interior designed to accommodate the placement of autologous bone graft.
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