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The UniSpace™ SA Cervical Cage is a standalone anterior cervical interbody fusion device indicated for skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. 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 by radios. The UniSpace™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. The cage of the UniSpace™ SA Cervical Cage must be used with the two internal fixation screws provided. UniSpace™ SA Cervical Cage implants with ≥ 20° lordosis must be used with an additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine," in addition to the two integrated fixation screws provided. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The UniSpace™ SA Cervical Cage is product for cervical spinal column stability. The implants of the UniSpace™ SA SA Cervical Cage consist of the cages manufactured through additive manufacturing (ASTM F3001) and the machined variable screws and locking cover plate (ASTM F136). The locking cover plate consists of a locking plate and a locking screw and is an optional device for the anti-backout of the variable screw. This optional implant can provide the more stability to prevent the anti-backout besides the self-locking mechanism. The cages and variable screws are offered in a variety of sizes to accommodate each patient's individual clinical case. The cages are designed to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The cage of the UniSpace™ SA Cervical Cage is provided as a sterile pack. The UniSpace™ SA Cervical Cage is implanted by using the instruments manufactured from stainless steel material that conform to ASTM F899.