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510(k) Data Aggregation

    K Number
    K152474
    Device Name
    Avitus Bone Harvester
    Manufacturer
    Avitus Orthopaedics Inc.
    Date Cleared
    2015-10-23

    (53 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Avitus Orthopaedics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Avitus(TM) Bone Harvester is intended to harvest cancellous bone and marrow
    Device Description
    The proposed device is a manual surgical instrument that cuts cancellous bone by manual actuation of the cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an ID of 6-10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressure between 150 mmHg. The proposed device can be connected to a waste canister that leads to standard operating room wall suction or to an external pump. With the device connected to a vacuum source, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bone graft inside the handle. The suction pulls the bone marrow from the cutting tip and into the bone reservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into the suction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bone graft can be retrieved from the handle.
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