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

    BACKTRAC 90-90 TRACTION

    K Number: K802869 · Decision Dec 11, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    BACKTRAC 90-90 TRACTION
    K Number
    K802869
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5890
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Backtrac
    Date Received
    November 14, 1980
    Decision Date
    December 11, 1980
    Product Code
    KQZ
    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
    KQZ Component, Traction, Non-Invasive

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