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

    SHOULDER NAIL PLATE

    K Number: K052294 · Decision Oct 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    7
    Review Days
    59

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    Basic Information

    Device Name
    SHOULDER NAIL PLATE
    K Number
    K052294
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hand Innovations, LLC
    Date Received
    August 23, 2005
    Decision Date
    October 21, 2005
    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 Hand Innovations, LLC

    K Number Device Name
    K061748 FRAGMENT PLATE SYSTEM
    K060864 MULTIDIRECTIONAL THREADED PEG
    K060294 DIAPHYSEAL PLATE
    K060290 SHOULDER FIXATION SYSTEM
    K052248 DORSAL NAIL PLATE, ANATOMICAL
    K051728 MODIFICATION TO SHOULDER FIXATION SYSTEM