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510(k) Data Aggregation

    K Number
    K000684

    Validate with FDA (Live)

    Device Name
    SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2000-04-28

    (59 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K011335,K033669,K050457,K051735,K060294,K060710,K062494,K063487,K063672,K072083,K081513,K082807,K090666,K101536,K103002,K103513,K110592,K111540,K112583,K112663,K113652,K113733,K113760,K120070,K120651,K120717,K120807,K120854,K121601,K122936,K130009,K133452,K133541,K140216,K140431,K140607,K141680,K143061,K150561,K152732,K153374,K153716,K160553,K161048,K161894,K162078,K163044,K163361,K163383,K170887,K171285,K181035,K181587,K191118,K191793,K193633,K193639,K201321,K223150,K230623,K231213,K233665,K233873,K243308,K243469,K242988
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

    Device Description

    The Small Fragment DCL system consists of limited-contact profile plates in straight, reconstruction, Oblique T- and Small T- plates of various sizes and 3.5 mm locking screws. The plates in this system also accept 2.7 mm and 3.5 mm cortex, and 4.0 mm cancellous screws. The plates feature a combination dynamic compression/locking screw hole. The system is available in either stainless steel or titanium.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

    The document is a safety and effectiveness summary for a traditional medical device (Synthes Small Fragment Dynamic Compression Locking (DCL) System) and is a 510(k) clearance letter from the FDA. It outlines the device description, indications for use, and its substantial equivalence to predicate devices, but lacks the specific details about AI/ML algorithm evaluation requested in your prompt.

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