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Approval for the post approval study. The device remains indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from l2-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Inter fix implants and inter fix rp implants are to be used with autogenous bone graft and implanted via an open anterior approach.
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