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

    BLADES FOR SPINAL LAMINECTOMY RETRACTOR

    K Number: K910621 · Decision Apr 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    5
    Review Days
    48

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    Basic Information

    Device Name
    BLADES FOR SPINAL LAMINECTOMY RETRACTOR
    K Number
    K910621
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    International Hospital Supply Co.
    Date Received
    February 12, 1991
    Decision Date
    April 1, 1991
    Product Code
    GZT
    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
    GZT Retractor, Self-Retaining, For Neurosurgery

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