Tag: Pedicle screws

icotec

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...
pedicle screw

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...