Vertebral body cement-containing implant

Definition
A sterile implantable device designed as a small pouch for percutaneous insertion into a vertebral body and inflated through the injection of orthopaedic cement, intended to provide a bone filler container (BFC) that ensures leakage-free containment of the cement within the vertebral body to restore its height during vertebroplasty and kyphoplasty. It is typically made of a non-bioabsorbable, non-stretchable fabric; implantation instruments may be included. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat patients diagnosed with vertebral compression fractures (VCFs) in the lumbar or thoracic region of the spine.
GUDID devices
6
Last updated
2021-10-26 02:38:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00815212023484KIT:VCF TREATMENT,RIGHT,FRACTUREIzi Medical Products, LLCKIV21002021-10-15
00815212023491KIT:VCF TREATMENT,LEFT,FRACTUREIzi Medical Products, LLCKIV22002021-10-15
00815212023507PILOT:GEN A,RIGHTIzi Medical Products, LLCPLT21002021-10-15
00815212023514PILOT:GEN A,LEFTIzi Medical Products, LLCPLT22002021-10-15
00815212023590KIVA ULTRAFLEX CEMENT NEEDLE KIT Izi Medical Products, LLCACC53502021-10-15
00815212023606KIVA INTRODUCER SETIzi Medical Products, LLCACC52702021-10-15