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510(k) Data Aggregation

    K Number
    K181086
    Device Name
    Cortical Fixation Systems
    Manufacturer
    Cousin Biotech S.A.S.
    Date Cleared
    2019-01-09

    (259 days)

    Product Code
    MBI, GAT
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cousin Biotech S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cortical Fixation Systems are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
    Device Description
    The Cortical Fixation Systems are available in two (2) models. The first one is the Cortical Fixation System (cortical button with fixed length loop). The second model is the Adjustable Cortical Fixation System (cortical button with adjustable length loop). These devices can be used with an Extended Plate which allows a larger surface of contact with the cortical bone. These products are anchor devices with titanium cortical button and are intended to be used as a soft tissue to bone fixation, especially for the ACL repair. The graft is passed through the loop and the titanium button ensures the tensioning and the fixation of the system.
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    K Number
    K181799
    Device Name
    ResCUBE™ Ligament Fixation System
    Manufacturer
    Cousin Biotech S.A.S.
    Date Cleared
    2018-08-29

    (55 days)

    Product Code
    OWI
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cousin Biotech S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ResCUBE System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, that can be treated with sublaminar, interspinous or facet wiring techniques. 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis and spondylolisthesis. 3. Spinal degenerative surgery, as an adjunct to spinal fusions.
    Device Description
    The ResCUBE™ Ligament Fixation System (ResCUBE System) is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The ResCUBE System consists of the following components: a ligament allowing correction and stabilization of the levels, after tensioning; a malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath; and a low-profile connector holding the tension on the ligament.
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    K Number
    K172206
    Device Name
    NAJA™ Ligament Correction System
    Manufacturer
    Cousin Biotech S.A.S.
    Date Cleared
    2018-04-10

    (263 days)

    Product Code
    OWI
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cousin Biotech S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NAJA System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques. 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis. 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The NAJA System may also be used in conjunction with other medical grade implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of the other implants.
    Device Description
    The NAJA™ Ligament Correction System (NAJA System) is a temporary implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The NAJA implant consists of a titanium alloy connector and a polyethylene terephthalate (PET) woven band. The NAJA System allows the spine to be secured to a rod construct without the use of a bone screw, and acts as an alternative to sublaminar wires and hooks.
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    K Number
    K133889
    Device Name
    PREMIUM
    Manufacturer
    COUSIN BIOTECH S.A.S.
    Date Cleared
    2014-09-04

    (258 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COUSIN BIOTECH S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PREMIUM are surgical meshes that are indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
    Device Description
    PREMIUM medical devices are surgical meshes with light polypropylene. They are non resorbable parietal reinforcement implants.
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    K Number
    K093196
    Device Name
    BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
    Manufacturer
    COUSIN BIOTECH S.A.S.
    Date Cleared
    2010-06-25

    (259 days)

    Product Code
    FTL, OQL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COUSIN BIOTECH S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BIOMESH® CA.B.S.'Air® Composite is intended for use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.
    Device Description
    BIOMESH® CA.B.S.'Air® Composite medical devices are parietal prosthesis with inflatable expansion balloon and fixation threads.
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    K Number
    K072962
    Device Name
    CABS'AIR
    Manufacturer
    COUSIN BIOTECH S.A.S.
    Date Cleared
    2008-06-26

    (251 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    COUSIN BIOTECH S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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