Tag: pedicle screw

Stryker reaches 100 surgeon milestone for “game-changing” Serrato screws

Stryker’s Serrato pedicle screws have been implanted by more than 100 surgeons across the USA during the first 30 days of limited release. A...

US FDA clears Stryker’s Serrato pedicle screw

Stryker’s Spine division has announced that its Serrato pedicle screw, intended for use in the non-cervical spine as part of the company’s Xia 3...

Full market release announced for Nexxt Spine’s Inertia Corti-fixx pedicle screw...

Nexxt Spine has announced the full market release of the company’s Inertia Corti-Fixx cortical-cancellous pedicle screw system. Corti-Fixx screws are designed to achieve greater...

GS Medical USA announces new product portfolio

GS Medical USA has announced the confirmed and pending launch of several US Food and Drug Administration (FDA) 510(k)-approved products. The company plans to launch...

US FDA clears SpineGuard’s DSG third-party pedicle screw integration module

SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new DSG (Dynamic Surgical Guidance) integration module to be...

US FDA downgrades class III pedicle screws to class II

The US Food and Drug Administration (FDA) has formally reclassified pedicle screws from class III to class II devices. The reclassification came into force...

Safe Orthopaedics receives CE mark for thoracic version of its Oak...

Safe Orthopaedics has received CE mark for a new version of its patented Oak screw, used to treat thoracic vertebral fractures. Previously, 7.5mm, 6.5mm and...

Signus receives US FDA 510(k) clearance for Diplomat posterior pedicle screw...

Signus has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new Diplomat pedicle screw system. The Diplomat has been developed...