BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

    K Number: K214109 · Decision Oct 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    303

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    Basic Information

    Device Name
    PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
    K Number
    K214109
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kontour(Xi’An) Medical Technology Co., Ltd.
    Date Received
    December 29, 2021
    Decision Date
    October 28, 2022
    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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