BDyn – EU MDR-Certified Posterior Dynamic Stabilization System
The BDyn device offers a solution for posterior dynamic spinal stabilization, certified under the EU MDR, designed for levels from T10 to sacrum S1.
Developed to treat certain lumbar degenerative conditions, BDyn provides controlled stabilization while preserving motion*.
MATERIAL
BDyn implant is a class III medical device. The CE conformity has been carried out by the notified body SGS Belgium NV (CE1639).
The BDyn instrument kit is composed of class Ir instruments medical devices manufactured by COUSIN BIOTECH S.A.S & Neuro France Implants. The management system of COUSIN BIOTECH S.A.S is certified for compliance with ISO 13485 standard. Please read carefully the instructions for use before using the device. The IFU is available electronically at: https://www.cousin-biotech.com/en/implant-notices
Cousin Biotech is the legal manufacturer of the medical devices proposed by Cousin Surgery.