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510(k) Data Aggregation

    K Number
    K160854
    Device Name
    MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture
    Manufacturer
    Biomet Manafacturing Corp.
    Date Cleared
    2016-12-19

    (266 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biomet Manafacturing Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MaxBraid BroadBand Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.
    Device Description
    Both MaxBraid BroadBand and Expressbraid Broadband Suture consist of a stainless steel straight or curved needle attached to a strand 1.25mm flat suture with round USP size 1 suture ends or 1.5mm flat suture with round USP size 2 suture ends in 38″ lengths. MaxBraid Broadband suture is straight with a single crimped needle, whereas the Expressbraid Broadband suture is a looped construct (both ends crimped into a single needle). The MaxBraid BroadBand Sutures are braided, non-absorbable sutures available in an all blue suture [Chromium-cobaltaluminum-oxide <2.0% by weight per 21 CFR §73.1015] consisting of Ultra High Molecular Weight Polyethylene (UHMWPE) fibers, a white and green [D&C Green No. 6 per 21 CFR §74.3206] co-braid configuration consisting of UHMWPE and polyester (PET) fibers, and a white and black [Logwood Extract per §73.1410] co-braid configuration consisting of UHMWPE and nylon. The suture is provided uncoated.
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