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

    Longeviti ClearFit Cranial Implant

    K Number: K191210 · Decision Jan 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    8
    Review Days
    248

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    Basic Information

    Device Name
    Longeviti ClearFit Cranial Implant
    K Number
    K191210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Longeviti Neuro Solutions, LLC
    Date Received
    May 6, 2019
    Decision Date
    January 9, 2020
    Product Code
    GXN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXN Plate, Cranioplasty, Preformed, Non-Alterable

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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
    K211514 Longeviti PorousFit implant
    K210616 Longeviti PMMA Static Cranial Implant
    K203349 Longeviti ClearFit Cranial Implant
    K202901 Longeviti ClearFit Cranial Implant
    K170410 Longeviti PMMA Static Cranial Implant