BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MP Pin flat without thread (36BMP000020/MP20)

    K Number: K240321 · Decision Oct 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    77
    Applicant Total
    5
    Review Days
    258

    Basic Information

    Device Name
    MP Pin flat without thread (36BMP000020/MP20)
    K Number
    K240321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hager & Meisinger GmbH
    Date Received
    February 2, 2024
    Decision Date
    October 17, 2024
    Product Code
    DZL
    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
    DZL Screw, Fixation, Intraosseous

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