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510(k) Data Aggregation

    K Number
    K234075
    Device Name
    Flow-Nail
    Manufacturer
    Date Cleared
    2024-02-05

    (26 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flow-FX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.
    Device Description
    The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a fenestrated lag screw, anti-rotation screw, cortical screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The purpose of this Special 510(k) is to add the 10mm IM Nail to the Flow-Nail System. The IM Nail (10mm) is manufactured from Ti-6Al-4V per ASTM F136. The components are provided non-sterile, for single use, by prescription only.
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    K Number
    K221115
    Device Name
    Flow-Nail
    Manufacturer
    Date Cleared
    2022-05-13

    (28 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flow-FX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.
    Device Description
    The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a fenestrated lag screw, anti-rotation screw, cortical screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The purpose of this Special 510(k) is to add Flow-Nail with Laglock to the Flow-Nail System. The components are provided non-sterile, for single use, by prescription only.
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    K Number
    K142776
    Device Name
    Flow-Screw
    Manufacturer
    Date Cleared
    2015-03-23

    (178 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Flow-FX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flow-Screw is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the Flow-Screw can also be used to deliver injectable bone void fillers to a surgical site.
    Device Description
    The Flow-Screw is cannulated and available in fully and partially threaded designs in various lengths. The Flow-Screw is fenestrated along its length which allows it to be used as a delivery system for injectable bone void fillers. The Flow-Screw implants are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or stainless steel conforming to ASTM F138 or ASTM F2229.
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    K Number
    K140601
    Device Name
    FLOW-NAIL
    Manufacturer
    Date Cleared
    2014-07-02

    (114 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLOW-FX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.
    Device Description
    The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a sliding fenestrated lag screw, anti-rotation screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136.
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