Spineart is thrilled to share a key milestone for the company: the PEEK Posterior Lumbar JULIET® cages as well as our PEEK Cervical TRYPTIK® cages and our Open and Minimally Invasive Thoracolumbar Fixation System ROMEO®2 are now CE Marked under the MDR 2017/745 (Medical Device Regulation) by the notified body TUV Sud. This is a step further towards our commitment to certify our complete portfolio under the MDR regulation by May 2024.
To achieve this goal, we are fully invested in advancing our quality system and clinical studies. What is MDR and why does it matter? The MDR is the set of regulations that control the design, clinical, production and distribution steps of medical devices in Europe entering in effect in May 2024. A number of requirements, such as technical files and clinical investigations, must be met in order to be compliant, which in turn ensures a higher level of patient safety.
About Spineart
Spineart’s mission is to transform spine surgery for patients, surgeons, and hospitals by developing procedures and medical devices that are safe and efficient, used by surgeons to enhance their patient’s life. True to its values: Quality, Innovation, Simplicity, Spineart is renown as a pioneer in the fields of disc prosthesis, simplification of surgical acts, 3D printed porous titanium and traceability of surgical implants. Today, Spineart remains at the forefront of its sector with the development of a complete portfolio of procedural solutions and digital technologies for surgical assistance. Spineart was awarded the “Prix de l’Economie Genevoise 2022” for its contribution to technological and scientific innovations, commercial activities, job creations and ESG principles.Please visit www.spineart.com