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510(k) Data Aggregation

    K Number
    K091531
    Device Name
    CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
    Manufacturer
    CHOICE SPINE, LLP
    Date Cleared
    2009-11-02

    (160 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHOICE SPINE, LLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.
    Device Description
    The Choice Spine Cervical Interbody Spacer System implants ("spacers") have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.
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