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510(k) Data Aggregation

    K Number
    K243281
    Device Name
    LOCK-IN Spinal Fixation System
    Manufacturer
    Date Cleared
    2024-12-13

    (57 days)

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

    LOCK-IN USA CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LOCK-IN Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. The LOCK-IN Spinal Fixation System is intended to be used with autograft and/or allograft.
    Device Description
    The LOCK-IN Spinal Fixation System is a spinal pedicle fixation system consisting of polyaxial pedicle screws (expandable and non-expandable; cannulated and non-cannulated), rods (straight and curved), rod lockers, and crosslinks. All components are manufactured from Ti-6Al-4V ELI titanium alloy. All screws are available with either standard or spondylolisthesis head configurations. Fixation is provided via a posterior approach. The LOCK-IN Spinal Fixation System expandable pedicle screws increase screw pullout strength when compared to similarly sized conventional screws. These screws are recommended for cases when increased fixation strength is desired. The LOCK-IN Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion in the non-cervical spine, including the thoracic, lumbar and/or sacral spine (T1- S5). The LOCK-IN Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, cross connectors that provide internal fixation and stabilization during bone graft healing and /or fusion mass development.
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