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

    NEWGEN/UNIVERSAL MANDIBULAR SYSTEM

    K Number: K014263 · Decision Mar 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    74
    Review Days
    71

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    Basic Information

    Device Name
    NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
    K Number
    K014263
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Instruments
    Date Received
    December 27, 2001
    Decision Date
    March 8, 2002
    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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