Polymeric spinal fusion cage, non-sterile

Intended purpose

Non-sterile Interbody Systems are intended for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1), or one level of the cervical spine (C2-T1) with accompanying radicular symptoms. Patients should have six months of non-operative treatment prior to surgery. Lumbar implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. Supplemental fixation must be used. This device must be sterilized prior to use