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

    TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM

    K Number: K896369 · Decision Nov 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    11
    Applicant Total
    31
    Review Days
    18

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    Basic Information

    Device Name
    TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM
    K Number
    K896369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Techmedica, Inc.
    Date Received
    November 6, 1989
    Decision Date
    November 24, 1989
    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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