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510(k) Data Aggregation

    K Number
    K091992
    Device Name
    EIDOSMED, MODEL EDG4.0
    Manufacturer
    Date Cleared
    2009-12-09

    (160 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    EIDOSMED, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Eidosmed EDG is a depth gauge measuring device intended for various medical purposes including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants.
    Device Description
    The Eidosmed Electronic Depth Gauge (“EDG”) is a depth gauge measuring device intended for various medical purposes, including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants. In addition to mechanically measuring and displaying depth using an analog scale, the EDG displays this information using a digital readout. The EDG, referred to as the EDG 4.0 version, is a completely disposable device. It is intended to be used on one patient, over the course of one surgical procedure.
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