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510(k) Data Aggregation

    K Number
    K200170
    Device Name
    SpineNet SSP System
    Manufacturer
    Date Cleared
    2020-02-05

    (13 days)

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

    SpineNet LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.
    Device Description
    The SpineNet SSP System is an anterior cervical plate and screw system which includes fixed and variable self-tapping screws and one- through four level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
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