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

    PATIENT SPECIFIC DISTAL FEMORAL

    K Number: K140898 · Decision Jan 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    8
    Review Days
    287

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    Basic Information

    Device Name
    PATIENT SPECIFIC DISTAL FEMORAL
    K Number
    K140898
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stanmore Implants Worldwide , Ltd.
    Date Received
    April 8, 2014
    Decision Date
    January 20, 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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    Other Clearances by Stanmore Implants Worldwide , Ltd.

    K Number Device Name
    K133152 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
    K121765 SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
    K121056 METS MODULAR PROXIMAL FEMUR
    K121029 METS MODULAR DISTAL FEMUR
    K121055 METS MODULAR TOTAL FEMUR
    K120992 METS SMILES TOTAL KNEE REPLACEMENT
    K092138 JTS EXTENDEABLE IMPLANT