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

    SCULPTOR ROBOTIC GUIDANCE ARM (RGA)

    K Number: K121765 · Decision Jan 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    8
    Review Days
    210

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    Basic Information

    Device Name
    SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
    K Number
    K121765
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stanmore Implants Worldwide , Ltd.
    Date Received
    June 15, 2012
    Decision Date
    January 11, 2013
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by Stanmore Implants Worldwide , Ltd.

    K Number Device Name
    K140898 PATIENT SPECIFIC DISTAL FEMORAL
    K133152 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
    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