Device Dossier
Spinal fixation plate, non-biodegradable
Device Dossier for Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class IIb, sponsor Precision Surgical). ARTG…
- GMDN category: Spinal fixation plate, non-biodegradable
Intended purpose
To provide stabilization of the anterior cervical spine (C2 to T1) as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, spinal stenosis, deformity (i.e. kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.