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510(k) Data Aggregation

    K Number
    K003205
    Device Name
    TRANSFX ANGLED RODS
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    2000-12-15

    (63 days)

    Product Code
    LXT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TRANSFX ANGLED RODS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fractures.

    Device Description

    TransFx Angled Rods

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the TransFX Angled Rods, indicating substantial equivalence to pre-amendment devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot fulfill your request using the provided input. This document is a regulatory clearance, not a technical performance report.

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