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510(k) Data Aggregation

    K Number
    K100382
    Device Name
    SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331
    Manufacturer
    SALUMEDICA, L.L.C.
    Date Cleared
    2010-08-05

    (170 days)

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

    SALUMEDICA, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SaluTunnel™ Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
    Device Description
    The SaluTunnel Nerve Protector is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury. The wall of the sheath has a longitudinal slit that allows SaluTunnel to be spread open for easy placement at the site of injury. The SaluTunnel Nerve Protector is designed to be interfaced between the nerve and its bed and, if necessary, to create a conduit for axonal growth across a nerve gap. SaluTunnel Nerve Protector is available in 2 through 10 mm inner diameter sizes. Each SaluTunnel device must be secured in place to prevent migration. Each SaluTunnel device should be chosen to be size appropriate. The device is manufactured from Salubria biomaterial. Salubria is made from a polymer (polyvinyl alcohol) and saline. Each SaluTunnel is provided sterile, hydrated in saline for presentation onto the operative field, for single use only.
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    K Number
    K002098
    Device Name
    SALUMEDICA NERVE CUFF
    Manufacturer
    SALUMEDICA, L.L.C.
    Date Cleared
    2000-11-24

    (136 days)

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

    SALUMEDICA, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity
    Device Description
    The Salumedica™ Nerve Cuff with Salubria™ biomaterial is a flexible tubular sheath developed to provide a protective environment for peripheral nerve repair after injury. The Salubria™ Norve Cuff is designed to be an interface between the nerve and its bed and to create a conduit for axonal growth across a nerve gap. The SaluMedica™ Nerve Cuff is available in sizes of 2, 5, and 10 mm inner diameters. Each Nerve Cuff is provided sterile, hydrated in saline for presentation onto the operative field.
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