Device Dossier

SUSTAIN® Posterior Lumbar Interbody Fusion (PLIF) - Spinal cage

Device Dossier for SUSTAIN® Posterior Lumbar Interbody Fusion (PLIF) - Spinal cage (Spinal cage, Class IIb, sponsor Globus Medical). ARTG record,…

Intended purpose

The SUSTAIN® Small Spacer and SUSTAIN® Radiolucent Small Spacer are interbody fusion devices intended foruse in the lumbosacral spine (L1-S1), for lumbar interbody fusion in the treatment of degenerative disorders of the lumbosacral spine. These spacers are recommended to be used with supplemental spinal fixation systems for the lumbosacral spine (e.g. pedicle screw and rod systems, or plates). The spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the spacer can be packed with bone grafting material.

TGA Public Summary