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

    MINI-H-FIXATION

    K Number: K792561 · Decision Dec 19, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    7

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    Basic Information

    Device Name
    MINI-H-FIXATION
    K Number
    K792561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Geny Medical, Inc.
    Date Received
    December 12, 1979
    Decision Date
    December 19, 1979
    Product Code
    JEC
    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
    JEC Component, Traction, Invasive

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