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

    E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT

    K Number: K043289 · Decision Feb 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    9
    Review Days
    74

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    Basic Information

    Device Name
    E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
    K Number
    K043289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signal Medical Corp.
    Date Received
    November 29, 2004
    Decision Date
    February 11, 2005
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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    K022382 RHS ACETABULAR COMPONENT
    K021063 GREAT TOE IMPLANT
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    K971018 SMC ACETABULAR COMPONENT