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

    POLI-AXIAL KNEE CAGE

    K Number: K812064 · Decision Aug 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    23

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    Basic Information

    Device Name
    POLI-AXIAL KNEE CAGE
    K Number
    K812064
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Generation II Orthotics, Inc.
    Date Received
    July 21, 1981
    Decision Date
    August 13, 1981
    Product Code
    ITM
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ITM Cage, Knee

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