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510(k) Data Aggregation

    K Number
    K122415
    Device Name
    X-FIX DYNAMIC EXTERNAL DISTRACTOR
    Manufacturer
    AREX USA LLC
    Date Cleared
    2013-03-15

    (219 days)

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

    AREX USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-FIX is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.
    Device Description
    The AREX USA X-FIX is a single use, lightweight, low profile external fixation system designed to treat fractures dislocations of the digits of the hand. The device is designed to help restore proper digit alignment and range of motion while permitting mobilization and normal anatomical movement.
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    K Number
    K094043
    Device Name
    LIGAMENTOTAXOR
    Manufacturer
    AREX USA
    Date Cleared
    2010-08-17

    (229 days)

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

    AREX USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.
    Device Description
    The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.
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    K Number
    K081011
    Device Name
    AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45
    Manufacturer
    AREX USA
    Date Cleared
    2008-11-07

    (212 days)

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

    AREX USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as non-unions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulmar styloid, capitellum, radial head and radial styloid.
    Device Description
    The AREX SCRU 2 Headless Compression Screws are cannulated, self drilling, self tapping, dual-pitch threaded devices which can be countersunk into the bone. The screw is available in titanium alloy with and OD of 2 5 or 3 mm and lengths from 10mm up to 45 mm, in increments of 5 mm. The screws are supplied non-sterile.
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