Tag: 510(k)

FDA 510(k) clearance for cervical and lumbar HA PEEK interbody...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for both the ALTA ACDF interbody spacers (Astura Medical) and HALF DOME lumbar...

Camber Spine announces 510(k) approval of ENZA-A titanium ALIF

The US Food and Drug Administration (FDA) has given 510(k) clearance to Camber Spine to market its ENZA-A titanium anterior lumbar interbody fusion (ALIF)...

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...