Superiority in any given surgery for any given device is one of the rarest, most elusive FDA designations available to medical device companies. In the world of treating single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis, only one manufacturer has ever achieved a superiority claim—that company is Premia Spine, and the implant is the Total Posterior Spine System (TOPS).
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TOPS vs Fusion: New Study Confirms Superiority
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