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510(k) Data Aggregation

    K Number
    K122437
    Device Name
    NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
    Manufacturer
    BIOMET SPORTS MEDICINE
    Date Cleared
    2013-10-18

    (434 days)

    Product Code
    MBI,HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K981967,K871037
    Why did this record match?
    Device Name :

    NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS

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

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

    Device Description

    The WasherLoc™ and No-Profile Screw and Washer Systems include titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 30mm to 70mm are available, with washer sizes in 14mm, 16mm, and 18mm diameters with and without spikes.

    AI/ML Overview

    The provided 510(k) summary describes a medical device, the WasherLoc™ and No-Profile Screw and Washer Systems, and its evaluation for MR compatibility. This summary does not contain information about an AI/ML powered device, therefore no information is available that could answer your questions.

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