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

    ANKLE-FOOT CAST/SPLINT

    K Number: K811690 · Decision Jun 25, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    503
    Registration Numbers
    503
    Same Product Code
    51
    Applicant Total
    9
    Review Days
    10

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    Basic Information

    Device Name
    ANKLE-FOOT CAST/SPLINT
    K Number
    K811690
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Surgical Appliance Industries, Inc.
    Date Received
    June 15, 1981
    Decision Date
    June 25, 1981
    Product Code
    IQI
    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
    IQI Orthosis, Limb Brace

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    Other Clearances by Surgical Appliance Industries, Inc.

    K Number Device Name
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    K821682 TRUNCAL ORTHOSIS
    K813416 EXTERNAL BREAST PROSTHESIS
    K812423 NEOPRENE KNEE SUPPORT
    K812401 CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O
    K812422 CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS
    K811689 CYLINDER KNEE CAST/SPLINT
    K811494 LUMBO-SACRAL FLEXION ORTHOSIS