4WEB Receives FDA Clearance for Cervical Stand Alone System

By Julie A. Vetalice

4WEB Medical received FDA 510(k) clearance for its Cervical Spine Truss System-Stand Alone (CSTS-SA) interbody fusion device. 

CSTS-SA incorporates 4WEB’s proprietary Truss Implant Technology. The interbody's design allows fixation screws to be placed through the truss implant and into the adjacent vertebral bodies, creating a zero-profile stand-alone construct. The 3D-printed device also features a single-step locking mechanism.

4WEB will launch the sterile-packed CSTS-SA in multiple footprints, lordotic angles and heights. The device is expected to be available in 4Q19.

Source: 4WEB Medical

 

Tags: 510(k) Clearance, Regulatory