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510(k) Data Aggregation

    K Number
    K981008
    Device Name
    SIMAL CERVICAL STABILIZATION SYSTEM
    Date Cleared
    1998-05-27

    (70 days)

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

    TOP SURGICAL PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the SIMAL Cervical Stabilization Device is anterior screw fixation of the cervical spine. Fixation is done via ventral or transoral approach. Indications for Use: Spondylolisthesis(instability), fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, or pseudarthrosis
    Device Description
    The SIMAL Cervical Stabilization System are screws and plates for anterior stabilization of the cervical spine and for anterior C2. C1 stabilization from the transoral approach. The anterior stabilization plates have large length varieties with four lengths per segment to fit all patient sizes. For the Trans-oral approach "winged" models secure placement of articular grafts. Both of the types of plates are anchored by titanium screws, which are available in various sizes.
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