BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPINAL WRENCH

    K Number: K813067 · Decision Nov 24, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    25

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    Basic Information

    Device Name
    SPINAL WRENCH
    K Number
    K813067
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Twin City Surgical, Inc.
    Date Received
    October 30, 1981
    Decision Date
    November 24, 1981
    Product Code
    HXC
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HXC Wrench

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