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

    MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM

    K Number: K051946 · Decision Aug 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    59
    Applicant Total
    5
    Review Days
    35

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    Basic Information

    Device Name
    MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
    K Number
    K051946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medartis, Inc.
    Date Received
    July 18, 2005
    Decision Date
    August 22, 2005
    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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