LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981967
    Device Name
    WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE
    Manufacturer
    ARTHROTEK/BIOMET, INC.
    Date Cleared
    1998-07-17

    (43 days)

    Product Code
    MBI,87M
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K871037,K962194
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARTHROTEK/BIOMET, INC.

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

    Soft tissue fixation to bone, specifically during ligament reconstructive procedures.

    Device Description

    Various style titanium alloy and stainless steel screws and washers. Screw diameters range from 3.5mm to 6.5mm and 10mm to 60mm in length. Washers have posts or spikes to engage the bone.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter for the "WasherLoc™ Screw System" and related soft tissue fixation screws. It discusses the regulatory classification, intended use, and general controls provisions of the Medical Device Amendments, but it does not detail any specific performance acceptance criteria or the results of a study designed to demonstrate them.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1