BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    LINK® MEGASYSTEM-C®

    K Number: K151008 · Decision Aug 26, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    42
    Review Days
    133

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    Basic Information

    Device Name
    LINK® MEGASYSTEM-C®
    K Number
    K151008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    April 15, 2015
    Decision Date
    August 26, 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 Waldemar Link GmbH & Co. KG

    K Number Device Name
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    K213770 SP-CL Hip Stem and LCU Hip System
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