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510(k) Data Aggregation

    K Number
    K212391
    Device Name
    MCI-Neuro Fixation System
    Manufacturer
    MCI Medical Concept Innovation Inc.
    Date Cleared
    2022-10-21

    (445 days)

    Product Code
    GWO, GXR, HBW
    Regulation Number
    882.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCI Medical Concept Innovation Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.
    Device Description
    The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized. MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use. The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.
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    K Number
    K182758
    Device Name
    MCI - CMF System
    Manufacturer
    MCI Medical Concept Innovation Inc.
    Date Cleared
    2019-12-05

    (433 days)

    Product Code
    JEY, DZL
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCI Medical Concept Innovation Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.
    Device Description
    The bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized. MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use.
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