Device Dossier
Spinal fixation plate, non-biodegradable
Device Dossier for Spinal fixation plate, non-biodegradable (Spinal fixation plate, non-biodegradable, Class IIb, sponsor Emergo). ARTG record, intended…
- GMDN category: Spinal fixation plate, non-biodegradable
Intended purpose
The E3D-A Interbody Coverplate is a component of the E3D-A Interbody System intended to provide immobilization and stabilization of spinal segments in skeletally mature patients in the treatment of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis), multilevel degenerative scoliosis or sagittal deformity.