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    K Number
    K122031
    Device Name
    NEXTRA TI HAMMERTOE CORRECTION SYSTEM
    Manufacturer
    NEXTREMITY SOLUTIONS, LLC
    Date Cleared
    2012-10-09

    (90 days)

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

    NEXTREMITY SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nextra™ Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
    Device Description
    The Nextremity Solutions Nextra™ Ti Hammertoe Correction (Nextra) System consists of proximal and distal components provided as a set with the necessary surgical site preparation and insertion instruments in a procedure pack. Nextra is fabricated from medical grade titanium alloy (6Al-4V) and the design allows the clinician to establish a natural angulation of the fused interdigital joint.
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    K Number
    K110445
    Device Name
    FLEXFUSION (TM) FIXATION IMPLANT
    Manufacturer
    NEXTREMITY SOLUTIONS, LLC
    Date Cleared
    2011-03-17

    (29 days)

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

    NEXTREMITY SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nextremity Solutions FlexFusion™ Fixation Implant is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
    Device Description
    The Nextremity Solutions 3.4mm FlexFusion™ Fixation implant system consists of a two-part 3.4mm diameter bone fixation implant. The proximal and distal components are provided as a set and as a procedure pack with the necessary surgical site preparation and insertion instruments. The Nextremity Solutions FlexFusion™ Fixation Implant is fabricated from medical grade stainless steel and the design allows the clinician to establish a natural angulation of the fused inter-digital joint.
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