www.fdanews.com/articles/179378-fda-grants-xtant-medical-clearance-to-use-allografts-in-the-stand-alone-irix-c-cervical-cage
FDA Grants Xtant Medical Clearance to Use Allografts in the Stand-Alone Irix-C Cervical Cage
November 18, 2016
The FDA has cleared the Irix-C cervical cage for use with autograft and/or allograft and the expansion of the range of levels allowable from C3-T1 to C2-T1.
Their allografts, 3Demin and OsteoSponge, will be used with Irix-C due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion.
The Irix-C is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C2-T1) in adult patients for treatment of degenerative disc disease.
These devices are available worldwide. — Cynthia Jessup