Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K230794
    Device Name
    Rebuilder Nerve Guidance Conduit
    Manufacturer
    CelestRay Biotech Company, LLC.,
    Date Cleared
    2024-01-29

    (313 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    CelestRay Biotech Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rebuilder Nerve Guidance Conduit is indicated for the reconstruction of a peripheral nerve discontinuity up to 20 mm in patients who have sustained a complete division of a nerve.
    Device Description
    The Rebuilder Nerve Guidance Conduit is designed to be a permeable and bioresorbable poly(lactide-co-caprolactone) based tube. It is designed to serve as an interface between the nerve and the surrounding tissue, providing a protective environment for peripheral nerve repair after injury. The Rebuilder Nerve Guidance Conduit offers guidance and protection for axonal growth across a nerve gap. The Rebuilder Nerve Guidance Conduit is provided sterile, non-pyrogenic, for single use only, in various sizes (with product inner diameter ranging from 1.5mm to 10 mm). The Rebuilder Nerve Guidance Conduit is provided in double peel package.
    Ask a Question
    K Number
    K222220
    Device Name
    SpinMedix Absorbable Fibrous Membrane
    Manufacturer
    CelestRay Biotech Company, LLC
    Date Cleared
    2023-07-06

    (346 days)

    Product Code
    OWW, FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CelestRay Biotech Company, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
    Device Description
    SpinMedix Absorbable Fibrous Membrane provides a non-constricting protective layer between the injured tissue and surrounding tissues and may be secured in place using standard fixation techniques. It is designed for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. SpinMedix is composed of poly (D, L-Lactide-co- Glycolide) and poly (D, L-Lactideb-Ethylene Glycol), and is provided in a variety of sizes, ranging from 25mm * 25mm to 200mm * 300mm. It is a single use, sterilized, porous, polymeric membrane in double peel packages.
    Ask a Question

    Page 1 of 1