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

    Stryker MP, Mandible, HMMF and MMF AXS Screws

    K Number: K231599 · Decision Aug 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    79
    Applicant Total
    21
    Review Days
    84

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    Basic Information

    Device Name
    Stryker MP, Mandible, HMMF and MMF AXS Screws
    K Number
    K231599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Leibinger GmbH & Co KG
    Date Received
    June 1, 2023
    Decision Date
    August 24, 2023
    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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