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510(k) Data Aggregation

    K Number
    K251790

    Validate with FDA (Live)

    Device Name
    SeptAlign
    Manufacturer
    Spirair, Inc.
    Date Cleared
    2026-01-16

    (219 days)

    Product Code
    MHB
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    All
    Reference & Predicate Devices
    K233569
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SeptAlign is used to support and straighten deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

    Device Description

    The SeptAlign System consists of a bioabsorbable implant and single use delivery device. The polydioxanone implant is 190 mm long and 0.65 mm thick with bi-directional anchors which enable mechanical correction of cartilaginous nasal septal deviations without cartilage resection. The implant also includes a surgical needle to enable placement which is trimmed off after use. The implant supports the cartilage in the straightened positioned as the cartilage remodels and is fully resorbed within a 6-month period.

    The implant is provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. SeptAlign is provided sterile and is intended for single-use only.

    AI/ML Overview

    N/A

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