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 lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels. These patients should be skeletally mature and have had six weeks of non-operative treatment. The cervical implants are also to be used with supplemental fixation; the hyperlordotic cervical implants (i.e., greater than or equal to 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.