Xtant Medical Receives CE Mark for Aranax and Irix-A

By Julie A. Vetalice

Xtant Medical received CE Mark approval for the Aranax™ cervical plate and the Irix-A™ standalone anterior lumbar fusion device.

Aranax comprises a pre-sterilized, ready-to-use implant, while Irix-A consists of an integrated, PEEK-enclosed titanium ring. In the U.S., Aranax received FDA 510(k) clearance in 3Q15, and Irix-A launched in 1Q15.

Source: Xtant Medical Holdings, Inc.

Product Labels: Cervical Spine, Lumbar Spine, Spinal Fusion

Tags: CE Mark, Regulatory