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510(k) Data Aggregation

    K Number
    K232572
    Device Name
    Kalitec Navigated Instrument System
    Date Cleared
    2023-12-13

    (111 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kalitec Direct, LLC doing business as Kalitec Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.
    Device Description
    The Kalitec Navigated Instrument System is comprised of nonsterile, reusable instruments, including probes, taps, and drivers that can be operated manually. These instruments are designed to function with the Medtronic StealthStation® S8(v2.0.1-7) System, in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®Il clamps and arrays to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Kalitec polyaxial screws.
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    K Number
    K230974
    Device Name
    NIDO™ Pedicle Screw System
    Manufacturer
    Date Cleared
    2023-09-15

    (163 days)

    Product Code
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kalitec Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIDO™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The NIDO™ Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion. The NIDO™ Pedicle Screw System Cannulated/Fenestrated Screws are intended to be used with saline and radiopaque dye.
    Device Description
    The NIDO™ Pedicle Screw System is a modular head, multiple component posterior spinal fixation system which consists of subject modular pedicle screw tulips, and rod connectors manufactured from Titanium alloy Ti-6Al-4V per ASTM F136. The subject pedicle screws are available in solid and cannulated/fenestrated configurations in various sizes to match patient anatomy. The fenestrated/cannulated screws are cannulated for use over a guidewire; they are fenestrated to allow the surgeon to apply a radiopaque dye or saline solution. The fenestrated/cannulated screws are not intended to allow for the use of bone cement. Screw tulips are available in standard, extended tab and closed styles, with a universal locking cap to lock the construct. Rod connectors are provided in domino, lateral and tulip styles. The subject components are intended for use with previously cleared rods and crosslinks connectors from the primary predicate Cosmolock Pedicle Screw System.
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    K Number
    K220902
    Device Name
    Navagio Lumbar Cage
    Date Cleared
    2022-05-27

    (60 days)

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

    Kalitec Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    2019-01-07

    (145 days)

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

    Kalitec Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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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