Paraspinous Tension Band Outperforms TLIF in FDA Trial

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Earlier this year, the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) to LimiFlex Paraspinous Tension Band, a motion preserving implant. Pre-market approval (PMA) is the most rigorous regulatory pathway any spinal implant can go through to reach commercial approval in the United States.

In this article, we review the clinical data that the FDA relied upon to approve Limiflex.