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510(k) Data Aggregation

    K Number
    K092531
    Device Name
    SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    SPINE 360
    Date Cleared
    2010-02-04

    (170 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
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    Applicant Name (Manufacturer) :

    SPINE 360

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spine 360 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications: - Degenerative disc disease [DDD] defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - . Spondylolisthesis - Spinal Stenosis . - Tumors . - . Trauma (i.e. fracture)
    Device Description
    The Spine 360 anterior cervical plates are provided preassembled and are offered with fixed angle bone screws. The system consists of four (4) primary components: 1) anterior plate, 2) self-tapping fixed angle bone screws, 3) locking shield screws and 4) locking shield.
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