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

    MOTECH TITANIUM SURGICAL MESH

    K Number: K900138 · Decision Mar 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    68

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    Basic Information

    Device Name
    MOTECH TITANIUM SURGICAL MESH
    K Number
    K900138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Biedermann Motech GmbH
    Date Received
    January 11, 1990
    Decision Date
    March 20, 1990
    Product Code
    EZX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EZX Mesh, Surgical, Metal

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