Tag: Pedicle screws
Woven Orthopedic secures US FDA 510(k) clearance for larger version of...
Woven Orthopedic Technologies has received its second 510(k) clearance from the US Food and Drug Administration (FDA) for the use of the Ogmend implant enhancement...
Neo Medical lands FDA approval and CE certification for Pedicle Screw...
Neo Medical has received US Food and Drug Administration (FDA) 510(k) clearance for the use of its Pedicle Screw System in late stage tumour...
Current evidence and future applications for robotics in spinal surgery
While robotic technology is still in its infancy, current evidence suggests a promising future for its application in spine surgery, argue Ronald A Lehman...
Alphatec advances InVictus MIS system with commercial launch of SingleStep
Alphatec Holdings announced today the commercial release of InVictus minimally invasive, or MIS, SingleStep K-wireless implant delivery system. By completely eliminating the requirement for...
Icotec earns FDA clearance for pedicle screw system
The US Food and Drug Administration (FDA) has granted Swiss devicemaker Icotec 510(k) clearance for its VADERone pedicle screw system, used for minimally-invasive and...
Microbes on explanted pedicle screws “may be a possible cause of...
According to a recent study, the low-virulent microorganisms frequently detected on pedicle screws by using sonication may be an important cause of implant loosening...
Banned in the USA: Petition calls for FDA to prohibit reprocessed...
Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA) has filed an official citizen...
FDA clearance for SAXXONY posterior cervical thoracic spine system
FDA 510(k) clearance has been granted for the SAXXONY posterior cervical thoracic system (Nexxt Spine). The system is designed to stabilise cervical (C1 to...
Increased radiation but “no benefits” in pedicle screw accuracy with navigation
A recent study found no improvements in pedicle screw accuracy but increased radiation using intraoperative computed tomography (CT)-based navigation compared to a freehand technique...
CTL Medical gains FDA clearance for Seurat Universal pedicle screw
CTL Medical has recently secured clearance from the US Food and Drug Administration (FDA) to market its new Seurat Universal pedicle screw system for...