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510(k) Data Aggregation

    K Number
    K090695
    Device Name
    DINKLER SURGICAL SKULL CLAMP, MODEL 0308
    Manufacturer
    DINKLER SURGICAL DEVICES, INC.
    Date Cleared
    2009-04-23

    (38 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    DINKLER SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dinkler Surgical Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
    Device Description
    The Dinkler Surgical Skull Clamp is a device used for rigid fixation of the skull. The design of the Skull Clamp allows the surgeon more freedom in positioning the skull pins. Avoidance of critical areas of the skull is made possible by a swiveling rocker arc which rotates 360°. The main body of the clamp is made from aluminum. The rocker arc assembly, which houses an additional skull pin, is made from stainless steel. A torque screw device on the main body of the clamp is used to apply load to the skull mainly for support and an additional torque screw, on the arc, provides load to resist head rotation. To accommodate the different sizes of patient heads, the skull clamp can be slid opened or closed and then locked.
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    K Number
    K073163
    Device Name
    LIMITED ARTIFACT SKULL PIN, MODEL 0107
    Manufacturer
    DINKLER SURGICAL DEVICES, INC.
    Date Cleared
    2008-02-28

    (111 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    DINKLER SURGICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Limited Artifact Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is required and during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field. The Limited Artifact Skull Pins are used in open and percutaneous craniotomies such as biopsies, thalamotomies and electrode implants; and in spinal surgeries when rigid skeletal fixation is necessary. The pins are also indicated for use during intra-operative use within a MR environment rated up to and including a 1.5 Tesla magnetic field.
    Device Description
    The Limited Artifact Skull Pins consists of an injection molded PEEK polymer base, a machined titanium pin tip, and an O-ring. These components are assembled to each other to represent the finished skull pin. The pins are packaged three (3) pins per pouch, twelve (12) pouches per carton and radiation sterilized.
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