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    K Number
    K033816
    Device Name
    SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2004-03-02

    (84 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM

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

    Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.

    Device Description

    The Synthes modified Sternal Reconstruction System contains a 1.0 mm stainless steel cable with detachable needle with ferrule The cable is 750 mm in length.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (a modification to a Sternal Reconstruction System), not a study analyzing device performance with acceptance criteria.

    Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or training/ground truth details.

    The document is a regulatory submission summary stating that the device is substantially equivalent to a predicate device, based on comparative information. It does not describe new performance testing against specific acceptance criteria.

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