Life Spine’s ARx sacral alar iliac spinal fixation system earned expanded 510(k) clearance from the FDA, according to an April 28 news release.
The system is now approved for use with compatible pedicle screws with 5.5mm or 6.0mm posterior rods made from either titanium alloys or cobalt chrome. Indication also includes screws from competing systems.
The ARx SAI spinal fixation system includes self-drilling screws for efficiency, a low-profile cobalt chrome tulip head and universal T25 hexalobe drive features.
“This clearance marks an important step forward in expanding surgical flexibility and access,” Rich Mueller, CEO of Life Spine, said in the release. “With ARx SAI approved for use with 5.5mm and 6.0mm posterior rods across titanium alloy and cobalt chrome systems, which now includes compatibility with competitive platforms, Life Spine can provide surgeons greater freedom to integrate our technology into their preferred posterior spinal constructs while maintaining the performance and reliability they expect.”
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