FDA Grants Clearance to Two VertiFlex Spine Systems

Spinal Tech

The FDA announced 510(k) clearance of two spine surgery devices from VertiFlex, the Totalis Direct Decompression System and the UniVise Spinous Process Fixation System. The Totalis Direct is a set of surgical instruments for minimally invasive direct lumbar decompressions. It uses both reusable and disposable instruments to remove targeted bone and soft tissue to treat spinal stenosis.

The UniVise implant system is used to provide fixation as an adjunct to lumbar spinal fusion.

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