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

    LIMITED ARTIFACT SKULL PIN, MODEL 0107

    K Number: K073163 · Decision Feb 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    111

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    Basic Information

    Device Name
    LIMITED ARTIFACT SKULL PIN, MODEL 0107
    K Number
    K073163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dinkler Surgical Devices, Inc.
    Date Received
    November 9, 2007
    Decision Date
    February 28, 2008
    Product Code
    HBL
    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
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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    Other Clearances by Dinkler Surgical Devices, Inc.

    K Number Device Name
    K090695 DINKLER SURGICAL SKULL CLAMP, MODEL 0308