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

    Longeviti PorousFit implant

    K Number: K211514 · Decision Jul 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    8
    Review Days
    59

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    Basic Information

    Device Name
    Longeviti PorousFit implant
    K Number
    K211514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Longeviti Neuro Solutions, LLC
    Date Received
    May 17, 2021
    Decision Date
    July 15, 2021
    Product Code
    KKY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

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    Other Clearances by Longeviti Neuro Solutions, LLC

    K Number Device Name
    K231920 Longeviti ClearFit OTS Cranial Implant
    K212058 Longeviti ClearFit™ OTS Cranial Implants
    K210616 Longeviti PMMA Static Cranial Implant
    K203349 Longeviti ClearFit Cranial Implant
    K202901 Longeviti ClearFit Cranial Implant
    K191210 Longeviti ClearFit Cranial Implant
    K170410 Longeviti PMMA Static Cranial Implant