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510(k) Data Aggregation

    K Number
    K082466
    Device Name
    XYCOR SPINAL IMPLANT
    Manufacturer
    VERTEBRATION,INC
    Date Cleared
    2009-01-09

    (135 days)

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

    VERTEBRATION,INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The XYcor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation for vertebral body replacement. The supplemental internal fixation systems that may be used with the XYcor™ System include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screwrod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems. The XY cor™ Spinal Implant is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e., facet screw fixation systems, facet compression devices, and posterior pedicle screw and rod systems).
    Device Description
    The XY cor™ Spinal Implant is a spinal implant fabricated from titanium that can be used as a vertebral body replacement device or an intervertebral body fusion device. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XYcor™ Spinal Implant V2-25 before and after deployment is of comparable size and shape to the other sizes of the XY cor™ implant.
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    K Number
    K070082
    Device Name
    XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY
    Manufacturer
    VERTEBRATION,INC
    Date Cleared
    2007-04-20

    (101 days)

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

    VERTEBRATION,INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The XY cor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the X Y cor™ System include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.
    Device Description
    The XYcor™ Spinal Implant is a vertebral body replacement device fabricated from titanium. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XY cor™ Spinal Implant prior to deployment is of comparable size and shape to the DEVEX™ System and, after deployment, is of comparable size to the InFix® System.
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