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510(k) Data Aggregation

    K Number
    K140675
    Device Name
    EMERGE EXTERNAL FIXATION SYSTEM
    Manufacturer
    EMERGE MEDICAL, INC.
    Date Cleared
    2014-06-10

    (84 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMERGE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. The system can be used for: Stabilization of soft tissues and fractures Polytrauma/multiple orthopedic trauma Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints Neutralization of fractures stabilized with limited internal fixation Non-unions/septic non-unions Intra-operative reductions/stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening
    Device Description
    The Emerge External Fixation System consists of combination clamp, rod-to-rod clamp, rods, pins, Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (3) 6L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber. The Emerge External Fixation System is provided non-sterile.
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