e1c922ee-fd38-423a-a241-d52c7ed1df37UpdatePublished22025-01-212024-01-11In Commercial Distribution08033860023980PrimaryGS1BIOPSYBELLRENOVA SPINE BALLOON CATHETERRESB15J438746708BIOPSYBELL SRL1REDUCTION AND FIXATION OF FRACTURES AND/OR CREATION OF A VOID IN CANCELLOUS BONE IN THE SPINE DURING BALLOON KYPHOPLASTY (FOR USE WITH CLEARED SPINAL POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENTS)falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+39053527850support@biopsybell.itK23134000058020Kyphoplasty balloon catheterA sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.falseActiveHRXArthroscopeNDNCement, Bone, VertebroplastyNeedle GaugeBalloon Lengthtruefalse