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510(k) Data Aggregation

    K Number
    K230067
    Device Name
    Para-Fix External Fixation System
    Manufacturer
    New Paradigm Biomedical
    Date Cleared
    2023-09-22

    (256 days)

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

    New Paradigm Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting. The specific indications for the Para-Fix External Fixation System include: · Bone fracture fixation · Osteotomy · Arthrodesis · Correction of deformity · Revision procedure where other treatments or devices have been unsuccessful · Bone reconstruction procedures
    Device Description
    The New Paradigm Biomedical (NPB) Para-Fix External Fixation System is intended for use in external fixation of various long bone fractures, including tibial, femoral, pelvic, and humeral fractures in adults. The Para-Fix system consists of implants, & instrumentation for external fixation. The system features implants (Schanz Screws) in various diameters (05 – 6mm) and lengths (120 – 300mm) to accommodate different anatomic sizes of patients. Schanz Screws are manufactured from medical grade stainless steel per ASTM F138. Para-Fix frame components include Clamps are available in Combination (pin to rod, rod to rod) or Multi-Pin clamps are manufactured from stainless steel. Ø11mm rods are available in lengths ranging from 65 – 500mm and are manufactured from carbon fiber. The Para-Fix system is provided non-sterile.
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