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510(k) Data Aggregation

    K Number
    K180222
    Device Name
    Reaxon Plus
    Manufacturer
    Date Cleared
    2018-04-24

    (89 days)

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

    Medovent GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Reaxon Plus is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
    Device Description
    Reaxon® Plus is a flexible and transparent chitosan based implant designed for repair of peripheral nerve discontinuities. Reaxon® Plus was developed to provide a protective environment for axonal growth across a nerve gap. When hydrated, Reaxon® Plus is an easy to handle, soft, pliable, transparent chitosan tube. Reaxon® Plus is provided sterile, non-pyrogenic, for single use in double blister packages in a variety of sizes as shown below.
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    K Number
    K143711
    Device Name
    Reaxon Plus
    Manufacturer
    Date Cleared
    2015-12-02

    (338 days)

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

    MEDOVENT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Reaxon® Plus is indicated for repair of peripheral nerve discontinuities up to 10 mm and where gap closure can be achieved by flexion of the extremity.
    Device Description
    Reaxon® Plus is a flexible and transparent chitosan based implant designed for repair of peripheral nerve discontinuities up to 10mm and where gap closure can be achieved by flexion of the extremity. Reaxon® Plus was developed to provide a protective environment for axonal growth across a nerve gap. When hydrated, Reaxon® Plus is an easy to handle, soft, pliable, transparent chitosan tube. Reaxon® Plus is provided sterile, non-pyrogenic, for single use in double blister packages in a variety of sizes as shown below.
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