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510(k) Data Aggregation

    K Number
    K181397
    Device Name
    DualX
    Manufacturer
    Innovasive, Inc.
    Date Cleared
    2018-09-27

    (121 days)

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

    Innovasive, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DualX™ PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DualXTM PLIF is indicated for unilateral or Bilateral implantation. The DualX™ LLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to L5, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DualX™ TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
    Device Description
    The DualX Implants are an expanding family of Interbody Fusion Devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery and, in the collapsed configuration, are between 12.3 mm wide (TLIF and PLIF) and 13.3mm wide (LLIF). After entering the joint space, the implants expand laterally to maximize the contact area around the cortical rim of the vertebral bodies. The implants then expand vertically to maintain destraction of the vertebral bodies and maximize clearance for exiting nerve roots. The implants are binary, and each implant can only be locked out in the fully expanded state. Specific sizes are included in the system with various expanded heights to optimize the fit for the patient. DualX Lumbar Intervertebral Body Fusion Device is made from titanium that conforms to ASTM F136.
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