Camber Spine earned FDA 510(k) approval for its Spira-A integrated fixation system.
The device is designed for anterior lumbar interbody fusion and allows packing with bone graft material, according to a July 23 news release. Spira-A is indicated for use at one or more levels in the lumbar spine for adults with degenerative disc disease, disc herniation spondylolisthesis, deformity, spinal stenosis and failed spinal fusion.
"The FDA's 510(k) clearance of our SPIRA-A Integrated technology ushers in the next evolution in our innovative SPIRA platform and marks another major step forward in our company's development," Camber Spine CEO Brooks McAdam said in the release. "It also helps bring more innovation-based solutions and options to the surgical community and a solution for surgeons engaging or wanting to engage in the ALIF market."