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

    Patient Specific Marking Guides

    K Number: K211076 · Decision Jun 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    26
    Applicant Total
    6
    Review Days
    442

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    Basic Information

    Device Name
    Patient Specific Marking Guides
    K Number
    K211076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Additive Orthopaedics, LLC
    Date Received
    April 12, 2021
    Decision Date
    June 28, 2022
    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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