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

    PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT

    K Number: K140900 · Decision Feb 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    1
    Review Days
    310

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    Basic Information

    Device Name
    PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
    K Number
    K140900
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stanmore Worldwide Implants , Ltd.
    Date Received
    April 8, 2014
    Decision Date
    February 12, 2015
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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