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

    LORENZ MANDIBULAR DISTRACTOR

    K Number: K955640 · Decision Feb 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    59
    Applicant Total
    441
    Review Days
    64

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    Basic Information

    Device Name
    LORENZ MANDIBULAR DISTRACTOR
    K Number
    K955640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet, Inc.
    Date Received
    December 12, 1995
    Decision Date
    February 14, 1996
    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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