Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K032102
    Device Name
    VERTELINK KOBRA SPINAL FIXATION SYSTEM
    Date Cleared
    2003-12-12

    (157 days)

    Product Code
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTELINK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spinal stenosis, 3) Spondylolisthesis, 4) Spinal deformities, 5) Fractures, 6) Pseudarthrosis,7) Tumor resection, 8) Failed previous Fusion. When used as Fixation system the multiaxial screw components are also indicated for skeletally mature patients: a. Having severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebral joint, b. Who are receiving fusion using authogeneous bone graft only, c. Who are having the device fixed or attached to the lumbar or sacral spine (L.3 and below), d. Who are having the device removed after the development of solid fusion mass.
    Device Description
    The Vertelink KOBRA™ Spinal Fixation System is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and pationic instabilities or deformities of the lumbar spine, spinal tumor and failed previous fusions. It can be used in either percutaneous or open surgery procedures. The system is composed of titanium pedicle screws and rods that are implanted in posterior manner either during an open surgical procedure or percutaneously using minimally invasive techniques.
    Ask a Question

    Ask a specific question about this device

    K Number
    K030734
    Device Name
    PATHWAY ACCESS SHEATH CATHETER
    Date Cleared
    2003-09-10

    (184 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTELINK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pathway™ Access Sheath Catheter is designed to facilitate the entry of interventional devices into the vessels of the cardiovascular system.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K030662
    Device Name
    PATHWAY ACCESS SHEATH CATHETER
    Date Cleared
    2003-09-03

    (184 days)

    Product Code
    Regulation Number
    876.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERTELINK CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The expandable sheath is designed especially for formation of large nephrostomy tracts required for percutaneous removal of renal and ureteral calculi.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1