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510(k) Data Aggregation

    K Number
    K192661
    Device Name
    LATERA Absorbable Nasal Implant System
    Manufacturer
    Entellus Medical, Inc. (Aka Stryker ENT)
    Date Cleared
    2019-11-10

    (46 days)

    Product Code
    NHB
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Entellus Medical, Inc. (Aka Stryker ENT)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.
    Device Description
    The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16-gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.
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