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510(k) Data Aggregation

    K Number
    K241219
    Device Name
    FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
    Manufacturer
    ZuriMed Technologies AG
    Date Cleared
    2024-12-11

    (224 days)

    Product Code
    OWX
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZuriMed Technologies AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fiber System is a single use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue. The Fiber Locker System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.
    Device Description
    The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue.
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