Device Dossier

Spinal cage

Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor Globus Medical). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

PATRIOT® Spacers (Colonial® ACDF) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one or more levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate System.

TGA Public Summary