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

    KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT

    K Number: K030237 · Decision Aug 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    32
    Applicant Total
    9
    Review Days
    218

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    Basic Information

    Device Name
    KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
    K Number
    K030237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3170
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kapp Surgical Instrument, Inc.
    Date Received
    January 23, 2003
    Decision Date
    August 29, 2003
    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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