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    K Number
    K252730
    Device Name
    Fule Spinal Fixation System
    Manufacturer
    Beijing Fule Science & Technology Development Co., Ltd.
    Date Cleared
    2025-10-24

    (57 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K111883
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fule Spinal Fixation System is a thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments (T1 to S2) as an adjunct to fusion in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (as confirmed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

    Device Description

    The Fule Spinal Fixation System consists of rods, polyaxial pedicle screws, set screws, and connectors, available in a range of sizes to accommodate different patient anatomies. Components are manufactured from titanium alloy (Ti6Al4V, ASTM F136) in accordance with ISO 5832-3.

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