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510(k) Data Aggregation

    K Number
    K252657
    Device Name
    Impact PEEK Union Nail System
    Manufacturer
    Nvision Biomedical Technologies INC.
    Date Cleared
    2025-09-19

    (28 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K250646,K143618,K160304
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

    Device Description

    The Impact PEEK Union Nail System represents a cutting-edge fixation device crafted from advanced HA Enhanced PEEK. The system is versatile, offering a range of lengths and diameters to suit various clinical needs, and features a cannulated design for precise k-wire guidance. Additionally, it integrates tantalum pins to ensure optimal imaging visibility, enhancing surgical accuracy and outcomes.

    AI/ML Overview

    N/A

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