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510(k) Data Aggregation

    K Number
    K091806
    Device Name
    POGO SCREW INSTRUMENTATION TRAY
    Manufacturer
    FXDEVICES
    Date Cleared
    2010-02-22

    (249 days)

    Product Code
    KCT, POG
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    FXDEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set. The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components. Sterilization Cycle Parameters Method: Steam Cycle: Pre-vacuum Temperature: 132ºC Exposure: 4 minutes Drying Time: 30 minutes or Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes
    Device Description
    The POGO Screw Instrumentation Tray is a custom autoclavable, compartmentalized, and perforated tray with a locking lid. It is intended to enclose and protect medicel device instrumentation, and to facilitate the sterilization process by allowing sterilant peneration and air removal. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap.
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    K Number
    K092189
    Device Name
    POGO SCREW
    Manufacturer
    FXDEVICES
    Date Cleared
    2009-09-18

    (59 days)

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

    FXDEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
    Device Description
    Dovice Bels.ipness are comprised of various size cannulated screws for the fixation of bone fractures. POGO screws are made of 316LVM Stainless Steel conforming to ASTM F138. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.
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    K Number
    K080649
    Device Name
    POGO SCREW
    Manufacturer
    FXDEVICES
    Date Cleared
    2008-11-25

    (263 days)

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

    FXDEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
    Device Description
    The POGO Screws are comprised of various size cannulated screws for the fixation of bone fractures. The components are manufactured from 316 surgical stainless steel. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.
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    K Number
    K070393
    Device Name
    LAGWIRE SYSTEM
    Manufacturer
    FXDEVICES
    Date Cleared
    2007-05-04

    (84 days)

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

    FXDEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lagwire is indicated for use in the general management of fractures and reconstructive surgery.
    Device Description
    The Lagwire fixation system consists of two (2) main components, a wire and a cap. The Lagwire materials are Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136. It is available as 4.5 mm diameter device and is obtainable in various length ranges. The Lagwire is provided sterile and intended for single use only.
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