Recently, China CMDE.NMPA published registration technical review report of composite plate system.
Product name: Composite Plate System
Product category: Class III
Applicant name: CarboFix Orthopedics Ltd.
Product structure and composition: This product consists of bone plates and bone screws. The bone plate is made of carbon fiber polyetheretherketone composite material. The material grade is PEEKPEEK-OPTIMA LT3PPT50A. The PEEK material used in this material complies with the YY/T 0660 standard. The bone plate has opaque positioning marks and is made of tantalum material (R05400) that complies with the YY/T 0966 standard. The bone screw is made of TC4ELI titanium alloy material that complies with the GB/T 13810 standard, and the surface is colored and anodized. The bone plate is packaged in sterile packaging and treated by steam sterilization. The sterility is valid for 5 years. Bone screws are non-sterile provided.
If you are interested in the original report, please feel free to send email: info@gvmmedical.com