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

    Biomet Microfixation OmniMax MMF System

    K Number: K202969 · Decision Aug 5, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    110
    Registration Numbers
    110
    Same Product Code
    288
    Applicant Total
    10
    Review Days
    309

    Basic Information

    Device Name
    Biomet Microfixation OmniMax MMF System
    K Number
    K202969
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Microfixation
    Date Received
    September 30, 2020
    Decision Date
    August 5, 2021
    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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