FDA Approves (PMA) Dynamic Sagittal Tethering for Spondy

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Premarket approvals are rare and come with substantially more clinical support than 510(k) clearances, so when the rare PMA is granted, it worth noting and in this case, celebrating.

The FDA has granted Premarket Approval to the LimiFlex™ Dynamic Sagittal Tether — a motion-preserving stabilization system designed for lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis following decompression.