Device typePolymeric spinal fusion cage, sterile: A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.
FDA categoryIntervertebral fusion device with bone graft, lumbar
Device ID00888480178026
Catalog number14-530433
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
SizeENCLAVE STRUT 13MM, 6DEG