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510(k) Data Aggregation

    K Number
    K251957
    Manufacturer
    Date Cleared
    2025-09-08

    (75 days)

    Product Code
    Regulation Number
    882.5270
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    COAPTIUM® Connect with TISSIUM® LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity.

    Device Description

    COAPTIUM® Connect is a bioabsorbable coaptation system for sutureless peripheral nerve repair of peripheral nerves not in continuity. The system includes a single-use syringe pre-filled with a photoactive COAPTIUM® polymer, which is used to secure an implantable three-dimensional coaptation chamber to the nerve segments that are distal and proximal to a peripheral nerve injury.

    The system includes implantable components, the coaptation chamber and the COAPTIUM® polymer, and three sterile disposable accessories: a silicone applicator (base and cap), a syringe tip, and a TISSIUM® Light Cover.

    The coaptation chamber and the COAPTIUM® polymer are designed to serve as a protective interface between the peripheral nerve and the surrounding tissues over time and create a conduit for axonal growth across a nerve gap, without the use of sutures. They are soft and flexible and degrade through hydrolysis with a bioabsorption profile that is compatible with nerve healing.

    The silicone applicator and syringe tip are designed to promote consistent and precise application of the COAPTIUM® polymer onto the coaptation chamber and adjacent peripheral nerve. The TISSIUM®
    Light Cover is for use with the reusable TISSIUM® LIGHT, which polymerizes the COAPTIUM® polymer on-demand.

    The components of COAPTIUM® CONNECT are supplied in single use sterile double peel packages and come in a variety of sizes. The TISSIUM® Light Cover is supplied in a single peel pouch and used as a sterile cover for the reusable TISSIUM® LIGHT.

    The TISSIUM® LIGHT is supplied separately and packaged in a single wall corrugated cardboard box.

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    K Number
    DEN240066
    Manufacturer
    Date Cleared
    2025-06-17

    (208 days)

    Product Code
    Regulation Number
    N/A
    Type
    Direct
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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