Evonik vestakeepreg; Peek has reached the number milestone approved by FDA
Evonik vestakeep reg; Peek has reached the number milestone approved by FDA
March 16, 2017
[China paint information]
vestakeep peek of Evonik is used by medical device customers to design and develop surgical implants, Recently, a milestone has been achieved: more than 80 devices using vestakeep peek have passed the approval of the U.S. Food and Drug Administration (FDA Europe will increase the use of carbon fiber composites as one of the lightweight materials in vehicles)
medical OEMs (factor 1: sensor OEMs) usually make their implants pass FDA testing in two ways. One is pre-sale licensing (PMA). This is the most rigorous process of FDA, which often requires years of testing and clinical trials to verify the safety and effectiveness of implants. The other is pre-sales notification, also known as 510k process, which is the most common and popular way. This process refers to a device that has been approved by FD and must clean reactor a after each batch of production, which usually takes only 90 days or less. Vestakeep peek has more than 80 customers' devices through the 510k process, and there are also devices using vestakeep peek through the more stringent PMA process, which fully shows that this is an outstanding material compared with the most demanding application requirements
vestakeep peek of Evonik was developed to meet the needs of the medical equipment industry for high-performance biocompatible materials. The high fatigue resistance and hardness of vestakeep peek are the key to the successful development of these medical devices, so that they can withstand high loads during surgery and subsequent healing processes. The system has the function of independent evaluation
as the darling of the medical equipment industry, vestakeep peek of Evonik is used for the development of medical equipment and technology in plastic surgery, spine, sports medicine, cardiovascular, limbs, craniomaxillofacial, dental and oncology markets. "Reaching this milestone with our customers fully demonstrates the acceptance and growth of vestakeep in the medical market." Vikram chatur, vice president and general manager of Evonik high performance polymers, said. "Because Evonik focuses on the medical equipment industry, we have such achievements today. Our advantage is R & D and innovation. We will continue to develop vestakeep series to increase our business scope and improve peek polymer technology to improve medical quality worldwide."
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