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

SABLE™ Expandable Spacer is a lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or more contiguous 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). The SABLE™ Expandable Spacer is to be filled with autogenous bone graft material, bone graft extenders, and/or bone graft substitutes. The device is intended to be used with supplemental fixation.

TGA Public Summary