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510(k) Data Aggregation

    K Number
    K041620
    Device Name
    NEURA WRAP NERVE PROTECTOR
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Date Cleared
    2004-07-16

    (30 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEURA WRAP NERVE PROTECTOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    NeuraWrap™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.

    Device Description

    NeuraWrap™ nerve protector is an absorbable collagen implant that provides a nonconstricting encasement for injured peripheral nerves for protection of the neural environment. NeuraWrap is designed to be an interface between the nerve and the surrounding tissue. When hydrated, NeuraWrap is an easy to handle, soft, pliable, nonfriable, porous collagen conduit. The wall of the conduit has a longitudinal slit that allows NeuraWrap to be spread open for easy placement over the injured nerve. The resilience of the collagen conduit allows NeuraWrap to recover and maintain closure once the device is placed around the nerve. NeuraWrap is provided sterile, non-pyrogenic, for single use only, in double peel packages in a variety of sizes.

    AI/ML Overview

    The provided text for the NeuraWrap™ Nerve Protector does not describe a study involving an AI/Machine Learning device. Therefore, it's not possible to generate the requested information based on your input.

    The document details a 510(k) submission for a physical medical device (an absorbable collagen implant) and focuses on its substantial equivalence to predicate devices, biocompatibility, and mechanical/physical property testing. It does not mention any AI components, algorithms, or performance metrics typically associated with AI/ML device evaluations.

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