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510(k) Data Aggregation

    K Number
    K214109
    Device Name
    PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
    Manufacturer
    Kontour(Xi’an) Medical Technology Co., Ltd.
    Date Cleared
    2022-10-28

    (303 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kontour(Xi’an) Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PEEK Patient Specific Cranial Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.
    Device Description
    The PEEK Patient Specific Cranial/Craniofacial Implants are designed individually for each patient to correct defects in cranial/facial bone, and fabricated using the patient' s CT imaging data. The implants are made of PEEK material which is medical grade material. The PSCI consists of PEEK bone plate, and it is fixated to native bone using previously cleared Bioplate Fixation System manufactured by Bioplate, Inc. The PSCI is provided in non-sterile and must be sterilized before use in Health Care Facility.
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