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

    CUSTOM CRANIOFACIAL IMPLANT (CCI)

    K Number: K121755 · Decision Sep 25, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    4
    Review Days
    102

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    Basic Information

    Device Name
    CUSTOM CRANIOFACIAL IMPLANT (CCI)
    K Number
    K121755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kelyniam Global, Inc.
    Date Received
    June 15, 2012
    Decision Date
    September 25, 2012
    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 Kelyniam Global, Inc.

    K Number Device Name
    K250334 Fusion Craniofacial Implant; Fusion Skull Implant
    K182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
    K103582 KELYNIAM CUSTOM SKULL IMPLANT (CSI)