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FDA Establishes Regulatory Review Period for Premia Spine's Total Posterior Spine System
July 07, 2025
WASHINGTON, July 7 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has determined the regulatory review period for the Total Posterior Spine System, a motion-preserving spinal implant developed by Premia Spine Ltd. The notice comes as Premia Spine seeks patent term extensions for several patents covering the innovative device.

The TOPS System is designed to stabilize the lumbar spine following decompression surgery without rigid fixation offe . . .

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