Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K250712
    Device Name
    Linkt Compression Staple System
    Manufacturer
    Trax Surgical
    Date Cleared
    2025-05-14

    (65 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trax Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Linkt™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
    Device Description
    The Linkt Compression Staple System consists of individually packaged, sterile, bone staple implants and a separate single use, sterile instrument set. The implants are manufactured from a nickel titanium alloy (Nitinol) which meets the requirements of ASTM F2063. The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The staples are available in sizes ranging from 9mm x 9mm to 20mm x 20mm to allow the surgeon to select the appropriate device for the patient's anatomy. The single use instruments are intended to prepare the site and deploy the staple. The instrument kit includes a drill, drill guide, locating pins and an insertion tool.
    Ask a Question
    K Number
    K230946
    Device Name
    Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L
    Manufacturer
    Trax Surgical
    Date Cleared
    2023-09-15

    (164 days)

    Product Code
    HWC, HTN
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Trax Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accelerate Compression Screw System is indust and skeletally mature pediatic patients (aged 12-21 years), for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
    Device Description
    The Trax Accelerate Compression Screw System is intended to be used to treat fracture and reconstruction of the small bones of the extremities (hands and feet). The screws are manufactured from 6AL-4V titanium and are anodized in various colors for easy size recognition. Washers will be provided for some screw sizes as appropriate. The fixation screws come in three (3) different configurations, headed, headless and break away. The headed and headless screws are cannulated. The breakaway screws are solid. They vary in diameter and length to allow the surgeon to select the appropriate device for the patient's anatomy. All devices are intended to be provided in an autoclavable instrument tray that includes a set of Class I instruments. The set will be provided non-sterile to the end user. The surgical instruments are intended to prepare the site and fixate the screws. The screws and instruments shall be designed to be maintained in an autoclavable tray. Replacement implants and instruments will be available separately as required.
    Ask a Question

    Page 1 of 1