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Found 8 results
510(k) Data Aggregation
K Number
K231920Device Name
Longeviti ClearFit OTS Cranial Implant
Manufacturer
Longeviti Neuro Solutions, LLC
Date Cleared
2023-11-09
(133 days)
Product Code
GXN
Regulation Number
882.5330Why 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
K212058Device Name
Longeviti ClearFit OTS Cranial Implants
Manufacturer
Longeviti Neuro Solutions, LLC
Date Cleared
2021-09-08
(69 days)
Product Code
GXN, PJN
Regulation Number
882.5330Why 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
K211514Device Name
Longeviti PorousFit implant
Manufacturer
Longeviti Neuro Solutions, LLC
Date Cleared
2021-07-15
(59 days)
Product Code
KKY
Regulation Number
878.3500Why 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
K210616Device Name
Longeviti PMMA Static Cranial Implant
Manufacturer
Longeviti Neuro Solutions, LLC
Date Cleared
2021-03-31
(30 days)
Product Code
GXN, PJN
Regulation Number
882.5330Why 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
K203349Device Name
Longeviti ClearFit Cranial Implant
Manufacturer
Longeviti Neuro Solutions, LLC
Date Cleared
2020-12-16
(33 days)
Product Code
GXN, PJN
Regulation Number
882.5330Why 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
K202901Device Name
Longeviti ClearFit Cranial Implant
Manufacturer
Longeviti Neuro Solutions, LLC
Date Cleared
2020-10-30
(31 days)
Product Code
GXN, PJN
Regulation Number
882.5330Why 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
K191210Device Name
Longeviti ClearFit Cranial Implant
Manufacturer
Longeviti Neuro Solutions, LLC
Date Cleared
2020-01-09
(248 days)
Product Code
GXN, PJN
Regulation Number
882.5330Why 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
K170410Device Name
Longeviti PMMA Static Cranial Implant
Manufacturer
Longeviti Neuro Solutions, LLC
Date Cleared
2018-03-23
(406 days)
Product Code
GXN, PJN
Regulation Number
882.5330Why 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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