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510(k) Data Aggregation
K Number
K100382Device 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
882.5275Why 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
K002098Device Name
SALUMEDICA NERVE CUFF
Manufacturer
SALUMEDICA, L.L.C.
Date Cleared
2000-11-24
(136 days)
Product Code
JXI
Regulation Number
882.5275Why 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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