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510(k) Data Aggregation

    K Number
    K100956
    Device Name
    SPONDY SPINAL FIXATION SYSTEM
    Manufacturer
    ALLURE SPINE L.L.C.
    Date Cleared
    2010-07-09

    (93 days)

    Product Code
    MNH,CLA,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K091725,K024096,K051216,K950099,K041449
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALLURE SPINE L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spondy™ Spinal Fixation System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization 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 the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

    In addition, when used as a pedicle screw fixation system, the Spondy Spinal Fixation System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (levels are L3-sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

    Device Description

    The Spondy Spinal Fixation System is a top-loading spinal fixation system consisting of polyaxial screws, set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbosacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy.

    AI/ML Overview

    The provided text describes a spinal fixation system, not an AI/ML powered medical device. Therefore, the requested information about acceptance criteria, study details (sample sizes, ground truth, experts, adjudication methods, MRMC studies, standalone performance), and training set information is not applicable.

    The submission is a 510(k) premarket notification for the "Spondy™ Spinal Fixation System," which is a physical medical device (implants for spinal stabilization and fusion). The performance data cited is mechanical and dynamic testing as per ASTM standards, not clinical studies involving AI models.

    Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance and validation studies based on the provided text.

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