FBC Device Gains FDA Clearance for Interbody Implant

By Julie A. Vetalice

FBC Device received its first FDA 510(k) clearance, granted for the FBC 921 ALIF interbody implant. The technology is a two-piece fusion device that allows for in situ adjustment from nine to 21 degrees, enabling surgeons to adjust alignment for each patient’s need and then lock the two pieces in place.

The company has also developed the Statur®-L spinal fusion device, which received CE Mark approval in 2013 ahead of launch in Canada and Europe. Statur-L, a hybrid of fusion and non-fusion technology, is designed to reduce the number of implants needed in a procedure, and study data has found that the device reduces relative movement between the implant and spinal bone.

Sources: FBC Device ApS; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory