Device Dossier
Spinal cage
Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor Emergo). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
- GMDN category: Spinal cage
Intended purpose
The TETRIS ST and TETRIS R ST devices are intended for use as an intervertebral fusion device at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.