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

    AXIA RADIAL HEAD SYSTEM

    K Number: K132735 · Decision Jan 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    126

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    Basic Information

    Device Name
    AXIA RADIAL HEAD SYSTEM
    K Number
    K132735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3170
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imds (Innovative MEdical Device Systems) - Leis ME
    Date Received
    September 3, 2013
    Decision Date
    January 7, 2014
    Product Code
    KWI
    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
    KWI Prosthesis, Elbow, Hemi-, Radial, Polymer

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