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510(k) Data Aggregation

    K Number
    K981967
    Device Name
    WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE
    Manufacturer
    ARTHROTEK/BIOMET, INC.
    Date Cleared
    1998-07-17

    (43 days)

    Product Code
    MBI, 87M
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTHROTEK/BIOMET, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
    Device Description
    Various style titanium alloy and stainless steel screws and washers. Screw diameters range from 3.5mm to 6.5mm and 10mm to 60mm in length. Washers have posts or spikes to engage the bone.
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