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510(k) Data Aggregation

    K Number
    K250197
    Device Name
    Estremo Fibular Nail
    Manufacturer
    Citieffe s.r.l.
    Date Cleared
    2025-10-17

    (267 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K173656,K192710
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Estremo Fibular Nail is intended for use in the fixation of fibula fractures and osteotomies.

    Device Description

    Estremo Fibular Nail includes all implants and instruments required for the fixation of fibula fractures and osteotomies. Estremo Fibular Nail includes the nails, screws, end caps and related instruments. Estremo Fibular Nail differs from traditional nails or rods as it utilizes a "Diapason wings deployment" mechanism at the proximal end of the rod to allow for proximal fixation with a screw. The implants are composed of 316L stainless steel per ASTM F138 and are provided sterile.

    AI/ML Overview

    N/A

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