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

    Cannulated Hemi Implant

    K Number: K190543 · Decision May 31, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    7
    Review Days
    88

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    Basic Information

    Device Name
    Cannulated Hemi Implant
    K Number
    K190543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3730
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vilex IN Tennessee, Inc.
    Date Received
    March 4, 2019
    Decision Date
    May 31, 2019
    Product Code
    KWD
    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
    KWD Prosthesis, Toe, Hemi-, Phalangeal

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