Zeniva® ZA-600 CF10 is a carbon-fiber reinforced grade of polyetheretherketone (PEEK) offered for use in implantable devices. The manufacturing facility for Zeniva® PEEK is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied. The biomaterial manufacturing processes are carefully validated, and enhanced controls provide product traceability. In addition, all materials are tested in a lab that is ISO 17025 accredited. The chemical, physical, and mechanical properties of finished parts are related to the processes utilized in producing the finished part (for example, molding, machining, annealing, sterilization, etc.). Zeniva® ZA-600 CF10 is offered as compounded pellets. An FDA MAF is available. Applications: Body Implants; Medical/Healthcare Applications Information provided by Solvay Specialty Polymers. |