2b765a2b-5a4e-435f-ab05-c5d984449536UpdatePublished22025-03-142024-02-23In Commercial Distribution08033860043643PrimaryGS1BIOPSYBELLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIPRESWB0812C-US438746708BIOPSYBELL SRL1KYPHOPLASTY WORKING CANNULA AND BEVEL TIPfalsetruefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+39053527850support@biopsybell.it58031Bone access channel kitA collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.falseActiveOCJSpinal Channeling Instrument, VertebroplastyNeedle GaugeLengthtruefalse