BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    EmbedMed

    K Number: K221943 · Decision Feb 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    211

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    Basic Information

    Device Name
    EmbedMed
    K Number
    K221943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3D Lifeprints UK , Ltd.
    Date Received
    July 5, 2022
    Decision Date
    February 1, 2023
    Product Code
    PBF
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PBF Orthopaedic Surgical Planning And Instrument Guides

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    Other Clearances by 3D Lifeprints UK , Ltd.

    K Number Device Name
    K220366 EmbedMed