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

CALIBER™ Spacers are interbody fusion devices intended for use in 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. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE or REVOLVE Stabilization Systems.

TGA Public Summary