![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » 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
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
Upcoming Events
-
21Oct