LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212197
    Device Name
    WasherCap Fixation System
    Manufacturer
    Abanza Tecnomed SL.
    Date Cleared
    2022-09-22

    (435 days)

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

    Abanza Tecnomed SL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
    Device Description
    WasherCap™ Fixation System is an implantable device indicated for soft tissue graft fastening during Anterior Cruciate Ligament repair surgery. WasherCap™ Fixation System consists of three components: a Cap, a Screw and a Washer. The Cap and the Washer are manufactured from polyetheretherketone (PEEK) as per ASTM F-2026. The Screw is made of titanium alloy as per ASTM F136. The WasherCap™ Fixation System is provided sterile and individually packaged and, it is available in a variety of sizes and should be implanted following the surgical procedure.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1