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510(k) Data Aggregation

    K Number
    K220902
    Device Name
    Navagio Lumbar Cage
    Manufacturer
    Kalitec Medical, LLC
    Date Cleared
    2022-05-27

    (60 days)

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

    Kalitec Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Navagio Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Navagio Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The Navagio Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
    Device Description
    The Navagio Lumbar Cage was developed as an implant for the stabilization of the lumbar spinal column. The Navagio implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows to receive bone graft, which helps facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery. The components are available in a variety of sizes to more closely match the patient's anatomy. Materials: Zeniva® ZA-500 PEEK conforming to ASTM F2026. Unalloyed tantalum (ASTM F560)
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    K Number
    K182210
    Device Name
    TiWAVE-L Porous Titanium Lumbar Cage
    Manufacturer
    Kalitec Medical, LLC
    Date Cleared
    2019-01-07

    (145 days)

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

    Kalitec Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TiWAVE-L™ Porous Titanium Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). TiWAVE-L Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The TiWAVE-L Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device
    Device Description
    The TiWAVE-L Porous Titanium Lumbar Cages are lumbar intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.
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