THIEBAUD

Thiebaud specializes in spinal fixation devices, including systems like the X’tens Kypho for internal fixation in the thoracic and lumbar spine, and the nano St’rim for minimally invasive spinal stabilization. Their portfolio also covers instrumentation for percutaneous pedicle screw placement and interbody fusion cages, all designed for surgical applications to address spinal deformities or stabilize vertebrae.

Thiebaud is based in France, which aligns its devices with the European Union’s regulatory framework. Since its products fall under EU Class IIa classification, they are registered in the EUDAMED database, ensuring compliance with the EU Medical Device Regulation (MDR) for safety, performance, and traceability.

Thiebaud’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices classified under EU regulations, including Thiebaud’s Class IIa spinal fixation systems.

Thiebaud’s devices are classified as EU Class IIa, which is the second-lowest risk category for medical devices in the EU. This classification requires compliance with specific regulatory requirements, including clinical evaluations and conformity assessments, to ensure their safety and performance before being registered in EUDAMED.