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

    IFS PROFILE PLATES, SCREWS, AND WASHERS

    K Number: K110086 · Decision Sep 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    4
    Review Days
    240

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    Basic Information

    Device Name
    IFS PROFILE PLATES, SCREWS, AND WASHERS
    K Number
    K110086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Internal Fixation Systems, Inc.
    Date Received
    January 12, 2011
    Decision Date
    September 9, 2011
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Internal Fixation Systems, Inc.

    K Number Device Name
    K113399 IFS SUBTALAR IMPLANT
    K071035 IFS BONE FIXATION DEVICES
    K061620 IFS CANNULATED BONE SCREW