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    K Number
    K231403
    Device Name
    evoDrill Cranial Perforator
    Manufacturer
    Evonos GmbH & Co. KG
    Date Cleared
    2024-03-06

    (296 days)

    Product Code
    HBF
    Regulation Number
    882.4305
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Evonos GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.
    Device Description
    The evonos evoDrill cranial perforator are single-use for trephining the cranial bone. The perforators have an automatic stop mechanism that stops the trephination process as soon as the skull bone has been pierced. The two variants evoDrill cranial perforator 3-flutes and evoDrill cranial perforator 4-flutes are available in two versions that are suitable for different bone thicknesses. The first version is used from bone thicknesses of 3mm, the second version is used for trepanation with bone thicknesses between 1mm and 3mm. Both variants are available in four different diameters. The evonos evoDrill cranial perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr holes through the skull of a patient. The evonos evoDrill cranial perforator are devices similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra Cut Automatic Cranial Drill DGR-1 #200-241; DGR-II #200-251 and Codman Disposable Perforators 26-1222, 26-1223). The evonos evoDrill cranial perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 RPM to 1500 RPM.
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