DevicePMAs@therightstef:P110008_S000 JSONTXT 11 Projects

Approval for the coflex interlaminar technology. This device is indicated for use in one- or two-level lumbar stenosis from l1- l5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/ groin pain, with or without back pain, and who have undergone at least 6 month of non-operative treatment. the coflex is intended to be implanted midline between adjacent lamina of 1 or 2 contiguous lumbar motion segments. interlaminar stabilization is performed after decompression of stenosis at the affected level(s).