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510(k) Data Aggregation

    K Number
    K112727
    Device Name
    MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
    Manufacturer
    MEDICAL FACETS
    Date Cleared
    2012-01-13

    (115 days)

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

    MEDICAL FACETS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Facet Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices
    Device Description
    Medical Facets Bone Screws are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium. Medical Facets External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium. Medical Facets Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm. 0.028 inches to 0.062 inches, in lengths ranging from 4.0 inches to 12.0 inches and are partially or completely threaded. or smooth. Made of stainless steel or titanium. Medical Facets Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt. Medical Facets Steinmann Pins are available in wire diameters ranging from 0.078 inches to 0.187 inches, in lengths ranging from 9.0 inches to 12.0 inches, are completely threaded, or smooth. Made of stainless steel or titanium.
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