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510(k) Data Aggregation
K Number
K180222Device Name
Reaxon Plus
Manufacturer
Date Cleared
2018-04-24
(89 days)
Product Code
Regulation Number
882.5275Why 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
K143711Device Name
Reaxon Plus
Manufacturer
Date Cleared
2015-12-02
(338 days)
Product Code
Regulation Number
882.5275Why 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.
Ask a Question
Ask a specific question about this device
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