Safe Group, a leading player in the field of medical devices for spine surgery, is pleased to announce that Frida, the innovative cervical plate developed by SpineUp, has received 510(k) clearance from the Food and Drug Administration (FDA). This clearance marks a crucial step in SpineUp’s expansion into the North American market, and testifies to its ongoing commitment to providing cutting-edge medical solutions.
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Frida is a new-generation cervical plate offering high adaptability with a multiplicity of plate and screw sizes. Thanks to this technology, healthcare professionals will be able to offer more personalized treatments, tailored to the specific needs of surgeons and their patients.
FDA 510(k) clearance is the result of several years of research and development. This certification attests to the safety and efficacy of the Frida solution, which complies with the FDA’s strict standards and is due to be marketed by the end of the year.
« In view of the merger of Safe’s subsidiaries with SpineUp, we are delighted that this authorization has been granted and that SpineUp has taken a major step forward, validating the company’s commitment to innovation and improving patient care,” says Victor Humberdot, Chairman of Safe Group.
“This new step heralds new business opportunities for SpineUp and its subsidiaries Safe Orthopaedics and Safe Medical, increased synergy and a stronger foothold in the U.S.” comments Philippe Laurito, President of SpineUp Inc.
