VertiFlex Inc. won a date with an FDA advisory panel to review the data behind its Superion interspinous spacer ahead of its bid for pre-market approval from the watchdog agency.
VertiFlex is seeking the FDA's permission to market the Superion in the U.S. under an indication for treating patients with lumbar spinal stenosis, according to a press release.
The FDA's Orthopaedic & Rehabilitation Devices panel is slated to meet Dec. 12 to evaluate the safety and efficacy data on the Superion, according to the release.
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