Zeniva? ZA-500 is a grade of polyetheretherketone (PEEK) offered for use in implantable devices.
The manufacturing facility for Zeniva? PEEK in Alpharetta, GA is ISO 13485 registered and the relevant aspects of current Good Manufacturing Practices are also applied. Our 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. This product meets the requirements of the current version of ASTM F 2026.
Zeniva? ZA-500 is offered as resin pellets and fabricated forms such as rods and plates. 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).
An FDA MAF is available and a PMDA MF is available in Japan.