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510(k) Data Aggregation

    K Number
    K221053
    Device Name
    Magnes-C Anterior Cervical Plate System
    Date Cleared
    2023-03-01

    (324 days)

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

    Fellowship of Orthopaedic Researchers, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Magnes-C™ Anterior Cervical Plate 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 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 Magnes-C™ Anterior Cervical Plate System components are intended for anterior screw fixation and stabilization of the cervical spine during the development of cervical interbody spinal fusion. The Magnes-C™ Anterior Cervical Plate System consists of one through three-level plates and fixed and variable screws, in a variety of sizes to accommodate individual patient anatomy. The Magnes-C components are provided nonsterile. Instruments to facilitate unilateral anterior fixation are included.
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