Tag: 510(k)

Medicrea files FDA 510(k) submission for 3D-printed titanium spinal devices

Medicrea has filed a 510(k) submission to the US Food and Drug Administration (FDA) for approval of the company’s 3D-printed titanium interbody devices, with...

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...