Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K191709
    Device Name
    V-STRUT Vertebral Implant
    Manufacturer
    Hyprevention SAS
    Date Cleared
    2020-03-05

    (253 days)

    Product Code
    NDN, LOD
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hyprevention SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with Teknimed F20® bone cement.
    Device Description
    V-STRUT© Vertebral Implant is part of V-STRUT© Transpedicular Vertebral System. V-STRUT© Transpedicular Vertebral System is composed of : - V-STRUT© Vertebral Implant, - -V-STRUT© Guide Wire, - -V-STRUT© Instrumentation Kit. V-STRUT© Vertebral Implant is a medical device to be placed in the vertebrae through a minimally invasive procedure. Two devices are implanted in each vertebra to be treated. Each implant is introduced posteriorly through the pedicle up to the anterior vertebral body wall. The implant is made of radio transparent polymer, PEEK (Polyetheretherketone as per ASTM F2026) and includes two visualizing markers made of tantalum (as per ASTM F560). V-STRUT© Vertebral Implant exists in 2 different diameters and 5 different lengths to accommodate individual patient's anatomy of thoracic and/or lumbar vertebrae from T9 to L5. V-STRUT© Vertebral Implant is provided sterile and is not reusable. V-STRUT© Vertebral Implanted using specific instrumentation provided with the implant and is combined in situ with a Polymethylmethacrylate (PMMA) bone cement, F20® manufactured by Teknimed SA (K103433).
    Ask a Question

    Page 1 of 1