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510(k) Data Aggregation

    K Number
    K231920
    Device Name
    Longeviti ClearFit OTS Cranial Implant
    Manufacturer
    Longeviti Neuro Solutions, LLC
    Date Cleared
    2023-11-09

    (133 days)

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

    Longeviti Neuro Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Longeviti ClearFit OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.
    Device Description
    The Longeviti ClearFit OTS (off-the shelf) cranial implants are ultrasound penetrable fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate (PMMA) materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.
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    K Number
    K212058
    Device Name
    Longeviti ClearFit™ OTS Cranial Implants
    Manufacturer
    Longeviti Neuro Solutions, LLC
    Date Cleared
    2021-09-08

    (69 days)

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

    Longeviti Neuro Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Longeviti ClearFit™ OTS Cranial Implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.
    Device Description
    The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.
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    K Number
    K211514
    Device Name
    Longeviti PorousFit implant
    Manufacturer
    Longeviti Neuro Solutions, LLC
    Date Cleared
    2021-07-15

    (59 days)

    Product Code
    KKY
    Regulation Number
    878.3500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Longeviti Neuro Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Longeviti PorousFit implants are anatomical shapes intended for non-weight bearing augmentation and/or restoration of contour within the craniofacial skeleton.
    Device Description
    Longeviti PorousFit implants are single-use, high density polyethylene (HDPE) for permanent implantation to restore the natural contour of the craniofacial skeleton. Devices are molded into various dimensions and shapes based on the area of the craniofacial skeleton requiring reconstruction and/or augmentation. PorousFit implants are provided sterile using ethylene oxide (EO).
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    K Number
    K210616
    Device Name
    Longeviti PMMA Static Cranial Implant
    Manufacturer
    Longeviti Neuro Solutions, LLC
    Date Cleared
    2021-03-31

    (30 days)

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

    Longeviti Neuro Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Longeviti ClearFit Cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defect of the cranium.
    Device Description
    Not Found
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    K Number
    K203349
    Device Name
    Longeviti ClearFit Cranial Implant
    Manufacturer
    Longeviti Neuro Solutions, LLC
    Date Cleared
    2020-12-16

    (33 days)

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

    Longeviti Neuro Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Longeviti ClearFit™ cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.
    Device Description
    The Longeviti ClearFit Implant is patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implant is manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. An identical backup implant may be supplied as a courtesy to the surgeon, according to custom, but is not required. The typical maximum single plate size does not exceed a total surface area of 411 cm2 and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity. Perfusion holes (also known as drainage holes) are available upon surgeon request at the time of ordering. Perfusion holes are 2mm in diameter and spaced at least 10mm apart.
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    K Number
    K202901
    Device Name
    Longeviti ClearFit Cranial Implant
    Manufacturer
    Longeviti Neuro Solutions, LLC
    Date Cleared
    2020-10-30

    (31 days)

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

    Longeviti Neuro Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Longeviti ClearFit™ Cranial Implant is designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.
    Device Description
    Not Found
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    K Number
    K191210
    Device Name
    Longeviti ClearFit Cranial Implant
    Manufacturer
    Longeviti Neuro Solutions, LLC
    Date Cleared
    2020-01-09

    (248 days)

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

    Longeviti Neuro Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Longeviti ClearFit™ Cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.
    Device Description
    The Longeviti ClearFit Implant is patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implant is manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. An identical backup implant may be supplied as a courtesy to the surgeon, according to custom, but is not required. The typical maximum single plate size does not exceed a total surface area of 411 cm² and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity. Perfusion holes (also known as drainage holes) are available upon surgeon request at the time of ordering. Perfusion holes are 2mm in diameter and spaced at least 10mm apart.
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    K Number
    K170410
    Device Name
    Longeviti PMMA Static Cranial Implant
    Manufacturer
    Longeviti Neuro Solutions, LLC
    Date Cleared
    2018-03-23

    (406 days)

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

    Longeviti Neuro Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Longeviti Static Cranial Implants are designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.
    Device Description
    The Longeviti PMMA Static Cranial Implants are patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. Typical maximum single plate sizes do not exceed a total surface area of 411 cm2 and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity.
    Ask a Question

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