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

    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

    K Number: K133152 · Decision Jan 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    82
    Applicant Total
    5
    Review Days
    61

    Basic Information

    Device Name
    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
    K Number
    K133152
    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
    November 22, 2013
    Decision Date
    January 22, 2014
    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
    K140898 PATIENT SPECIFIC DISTAL FEMORAL
    K121056 METS MODULAR PROXIMAL FEMUR
    K121055 METS MODULAR TOTAL FEMUR
    K092138 JTS EXTENDEABLE IMPLANT