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510(k) Data Aggregation

    K Number
    K991723
    Device Name
    TRANSFX MULTI PIN CLAMP
    Manufacturer
    IMMEDICA, INC.
    Date Cleared
    1999-07-22

    (63 days)

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

    TRANSFX MULTI PIN CLAMP

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

    Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary Exation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.

    Device Description

    TransFx Multi-Pin Clamp

    AI/ML Overview

    The provided document, an FDA 510(k) clearance letter for the TransFx Multi Pin Clamp, does not contain information about acceptance criteria, device performance studies, or any of the detailed technical study parameters requested.

    This document is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report. Therefore, I cannot generate the requested table and study details from the provided text.

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