2409f7e4-1462-479e-9f9e-290eed6af289UpdatePublished22024-04-262023-12-19In Commercial Distribution00842166196742PrimaryGS1ZavationVCF-1025069472800Zavation LLC1BEVELED TROCAR falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse601-919-1119info@zavation.com47129Balloon kyphoplasty kitA collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.falseActiveNDNCement, Bone, VertebroplastyHRXArthroscopeGAANeedle, Aspiration And Injection, DisposabletruetrueEthylene Oxide