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

    MATRIXWAVE MMF SYSTEM

    K Number: K141165 · Decision Oct 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    45
    Review Days
    164

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    Basic Information

    Device Name
    MATRIXWAVE MMF SYSTEM
    K Number
    K141165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (USA) Products, LLC
    Date Received
    May 6, 2014
    Decision Date
    October 17, 2014
    Product Code
    JEY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JEY Plate, Bone

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