coflex® implant
Stability and freedom of movement for the spine.
The coflex® implant is a minimally invasive solution for lumbar spinal stenosis.
Its unique titanium design combines stability with natural motion preservation, supporting patients with stenosis or mild degenerative instability.
NOTE: The coflex® stabilization system is available in the United States as an FDA PMA-approved Device.
Intended Purpose
US
The coflex® Interlaminar Technology is an interlaminar stabilization device 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 months 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).
EUROPEAN UNION
The coflex® implant is intended for permanent implantation between the spinous processes of 1 or 2 lumbar motion segments and controls segmental motion in cases of lumbar stenosis or mild degenerative instability.
Implantation Parameters
Please refer to the applicable regional Instructions for Use (IFU), indications, contraindications, and regulatory approvals relevant to your country or market prior to use, as device indications and requirements may vary by jurisdiction.
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