Safe Group Announces FDA 510(k) Clearance for SpineUp's Frida Solution

6 June 2025

Safe Group, a leading provider of medical devices for spinal surgery, is pleased to announce that Frida, the innovative cervical plate developed by SpineUp, has been granted 510(k) clearance by the Food and Drug Administration (FDA). This clearance marks a crucial milestone in SpineUp's expansion into the North American market and demonstrates its continued commitment to providing cutting-edge medical solutions.

Frida is a state-of-the-art cervical plate offering high adaptability with a variety of plate and screw sizes. This technology will enable healthcare professionals to offer more personalized treatments, meeting the specific needs of surgeons and their patients.

Obtaining the FDA's 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, in accordance with strict FDA standards, and it is expected to be commercially available by the end of the year.

"  With the merger of Safe's subsidiaries with SpineUp in mind, we are delighted to have obtained this authorization and to welcome the significant step taken by SpineUp, which validates the company's commitment to innovating and improving patient care," said Victor Humberdot, President of Safe Group.

"This new step heralds new opportunities for SpineUp and its subsidiaries Safe Orthopaedics and Safe Medical, increased synergy and a stronger foothold in the United States, " comments Philippe Laurito, President of SpineUp Inc.

 

Source: globenewswire.com