The system is based on the company’s proprietary rhenium alloys and is designed for cervical and upper thoracic spine care, according to a news release. It is built around a 2.9 mm rod that allows for low-profile pedicle screw tulips for less invasive surgery.
Breakthrough device designation will let the company work with FDA experts through the premarket review phase and prioritize submission review, according to the agency’s website.
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