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510(k) Data Aggregation

    K Number
    K032966
    Device Name
    THE ANSWER SCREW SUPPLEMENTATION SYSTEM
    Manufacturer
    SIMPLICITY ORTHOPEDIC SOLUTIONS, LLC
    Date Cleared
    2004-01-13

    (112 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIMPLICITY ORTHOPEDIC SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used for internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws. It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine.
    Device Description
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