Spinal cage

Intended purpose

Amendia Intervertebral Body Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical and lumbar spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. For lumbar fusion, these DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. These implants are to be used with autogenous bone graft and implanted via various approaches. The intervertebral cages are to be used with supplemental fixation. Patients should have at least six (6) weeks (cervical fusion) or six (6) months (lumbar fusion) of non-operative treatment prior to treatment with an intervertebral cage.