Safe Group, a manufacturer of medical devices for spine surgery, has announced 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, the company said in a statement.

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 personalised treatments, tailored to the specific needs of surgeons and their patients.

“In view of the merger of Safe's subsidiaries with SpineUp, we are delighted that this authorisation has been granted and that SpineUp has taken a major step forward, validating the company's commitment to innovation and improving patient care,” said 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 US,” remarked Philippe Laurito, President of SpineUp Inc.

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, it said.