HEDRON Cervical Spacer - Spinal cage

Intended purpose

HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed with radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. HEDRON C™ Spacers and HEDRON IC™ Spacers are recommended to be used with supplemental fixation systems for the cervical spine, (e.g. anterior cervical plates). These spacers are to be filled with autogenous bone graft material, bone graft extender, and/ or bone graft substitutes. When the HEDRON IC™ Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC™ Plate-Spacer)is a stand-alone device intended for use at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium screws which accompany the implant. The spacer is to be filled with autogenous bone graft material, bone graft extender, and/or bone graft substitutes.