Icotec’s 4.5mm pedicle screws earn FDA clearance

The FDA cleared Icotec’s Vader pedicle system to include 4.5 mm pedicle screws and extended carbon/PEEK rods, the devicemaker said Jan. 24. 

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The extended Vader system adds options for stabilizing the upper-thoracic spine, according to a news release. Icotec’s system is reportedly the world’s first 4.5mm carbon/PEEK and and extended rod portfolio in the U.S.

The system’s BlackArmor implants provide more options for patients with spinal tumors and now includes pedicle screws between 4.5mm and 7.5mm in length. 

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