Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K161191
    Device Name
    Latera Absorbable Nasal Implant
    Manufacturer
    SPIROX, INC.
    Date Cleared
    2016-06-23

    (57 days)

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

    SPIROX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirox Latera Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
    Device Description
    The Spirox Latera Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the Latera Absorbable Nasal Implant) and Accessory Delivery Device (Delivery Device). The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and overall length of 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. The Latera Absorbable Nasal Implant and Accessory Delivery Device are provided sterile and are intended for single-use only.
    Ask a Question
    K Number
    K152958
    Device Name
    INEX Absorbable Nasal Implant
    Manufacturer
    SPIROX, INC.
    Date Cleared
    2015-12-04

    (58 days)

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

    SPIROX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirox INEX Absorbable Nasal Implant is indicated for supporting nasal upper and lower lateral cartilage.
    Device Description
    The Spirox INEX Absorbable Nasal Implant System is intended to support cartilage in the nasal lateral wall. The System consists of the INEX Absorbable Nasal Implant and accessory Delivery Tool. The implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and an overall length of 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 Tool is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16 gauge delivery cannula. The Delivery Tool enables placement of the implant in a minimally invasive manner. The INEX Absorbable Nasal Implant and accessory Delivery Tool are provided sterile and are intended for single-use only.
    Ask a Question
    K Number
    K132920
    Device Name
    SPIROX INEX DEVICE
    Manufacturer
    SPIROX, INC.
    Date Cleared
    2014-06-10

    (266 days)

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

    SPIROX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.
    Device Description
    The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide) 70:30. The product is provided as a perforated sheet comprised of multiple "rod" like elements. The sheet is nominally 24.5 x 20.0 mm with a thickness of 1.1 mm. The bridge sections are nominally 3.0 x 1.9 mm and the voids are nominally 2.4 x 1.9 mm. The implant can be trimmed and shaped to dimensions suitable for the surgical need. The device is implanted using standard surgical tools and techniques The Spirox INEX implantable sheet is a sterile, single use device.
    Ask a Question

    Page 1 of 1