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510(k) Data Aggregation

    K Number
    K011946
    Device Name
    THE SPIN SNAP-OFF SCREW
    Manufacturer
    NEW DEAL, S.A.
    Date Cleared
    2001-08-24

    (64 days)

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

    NEW DEAL, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "new" SPIN® SNAP-OFF SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of small bone fragments. Weil osteotomy Mono-cortical fixation Osteotomies and fractures fixation in the foot and hand
    Device Description
    The SPIN ® SNAP-OFF SCREW is self drilling and self tapping snap-off screw One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. In comes in lengths from 11 to 14 mm. The length varies whereas the head diameter is constant ( 2 mm) and the distal thread length is 7 mm to 10 mm.
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