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

    ENDURO KNEE SYSTEM

    K Number: K101815 · Decision Dec 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    7
    Review Days
    173

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    Basic Information

    Device Name
    ENDURO KNEE SYSTEM
    K Number
    K101815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap Implant Systems
    Date Received
    June 30, 2010
    Decision Date
    December 20, 2010
    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 Aesculap Implant Systems

    K Number Device Name
    K140452 VEGA KNEE SYSTEM
    K121879 VEGA KNEE SYSTEM
    K100623 AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
    K090299 BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
    K090657 MODIFICATION TO: S4 SPINAL SYSTEM
    K071945 S4 SPINAL SYSTEM