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

    DePuy Synthes Maxillofacial Portfolio - MR Conditional

    K Number: K183113 · Decision Mar 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    59
    Applicant Total
    45
    Review Days
    124

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    Basic Information

    Device Name
    DePuy Synthes Maxillofacial Portfolio - MR Conditional
    K Number
    K183113
    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
    November 9, 2018
    Decision Date
    March 13, 2019
    Product Code
    MQN
    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
    MQN External Mandibular Fixator And/Or Distractor

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