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510(k) Data Aggregation

    K Number
    K123997
    Device Name
    TRANS1LATERAL INTERBODY FUSION SYSTEM
    Manufacturer
    TRANS1, INC.
    Date Cleared
    2013-04-01

    (96 days)

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

    TRANS1, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VEO is indicated for 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 DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. VEO is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.
    Device Description
    VEO is a radiolucent PEEK interbody fusion implant comprised of various heights to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The lateral access technique allows a large cage to be implanted similar to marketed lateral lumbar interbody fusion sized cages. It is designed for use to provide structural stability in skeletally mature individuals.
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    K Number
    K040426
    Device Name
    TRANS1 AXIAL FIXATION SYSTEM
    Manufacturer
    TRANS1, INC.
    Date Cleared
    2004-12-17

    (302 days)

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

    TRANS1, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TranS1™ Axial Fixation System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1™ Axial Fixation System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed pedicle screw systems.
    Device Description
    The TranS1 Axial Fixation System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. The following components are included: 3D Axial Fixation Threaded Rod/Screw, Axial Fixation Screw Plug, Axial Fixation Screw Driver, Material Inserter, and Axial Fixation Screw Plug Driver.
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    K Number
    K032891
    Device Name
    TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
    Manufacturer
    TRANS1, INC.
    Date Cleared
    2004-01-15

    (120 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANS1, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5-S1 interbody fusion.
    Device Description
    The Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior lower spine and consists of the following components: Guide Pin Introducer Guide Pins Dilators Dilators with sheath Guide Pin Steering Handle Twist Drills Cutters Brushs Exchange Rod Exchange Cannula Brush Delivery Sleeve Distraction Tool with driver Bone Graft Inserter Fibula Placement Tool
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