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510(k) Data Aggregation

    K Number
    K182352
    Device Name
    SP-LINK™ System
    Date Cleared
    2018-11-21

    (84 days)

    Product Code
    Regulation Number
    888.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medical Designs LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SP-LINK™ System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for single level plate attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SP-LINK™ System is intended for use with bone graft material, and not for stand-alone use.
    Device Description
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