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

    DINKLER SURGICAL SKULL CLAMP, MODEL 0308

    K Number: K090695 · Decision Apr 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    38

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    Basic Information

    Device Name
    DINKLER SURGICAL SKULL CLAMP, MODEL 0308
    K Number
    K090695
    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
    March 16, 2009
    Decision Date
    April 23, 2009
    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
    K073163 LIMITED ARTIFACT SKULL PIN, MODEL 0107