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 (Constitution™ PLIF, Continental® ALIF, TransContinental™ LLIF and Signature® TLIF Spacers) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) at one or more levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.

TGA Public Summary