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510(k) Data Aggregation

    K Number
    K965028
    Device Name
    ACUMED SUTURE WASHER
    Manufacturer
    ACUMED, INC.
    Date Cleared
    1997-03-17

    (90 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K984458,K990392
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine.

    Device Description

    This washer has a post height of 2.6mm and an outer diameter of 8.0mm. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided sterile. Sterility is achieved by a minimum of 2.5 Mrads gamma radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility assurance level is 104.

    AI/ML Overview

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