BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STRYKER TWIST DRILLS

    K Number: K070876 · Decision Apr 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    3
    Review Days
    29

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    Basic Information

    Device Name
    STRYKER TWIST DRILLS
    K Number
    K070876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Craniomaxillofacial
    Date Received
    March 29, 2007
    Decision Date
    April 27, 2007
    Product Code
    HBE
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

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    Other Clearances by Stryker Craniomaxillofacial

    K Number Device Name
    K232350 Stryker Facial iD System
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