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Medical implant grade AKSOPEEK material has passed the master file filing of the Food and Drug Administration

Category: Company News, News Date: 2023-12-12 Reading volume: 22

In December 2023, the AKSOPEEK medical implant-grade material independently developed by Changzhou Junhua Medical Technology Co., Ltd. successfully passed the main file filing of the State Food and Drug Administration, registration number: M2023173-000.

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The materials filed here include relevant information on AKSOPEEK plate, rod, profile and particles. When using AKSOPEEK implant-grade materials to register medical device products, the partners of Changzhou Junhua Medical do not need to submit registration information repeatedly. They only need to obtain our company’s master document retrieval authorization letter, which can greatly simplify the registration process and shorten the registration time.

 

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Health●Safety●Wisdom

AKSO has a profound meaning and represents the goddess of health in ancient Greek mythology. In the West, AKSO is well known as a product name and is recognized as a pharmaceutical product.

The graphic is a deformation of the “O” of AKSO, combined with the image of the goddess of health in Greek mythology: a young woman holding a bowl with a snake in it. In Greek religion, she is the god of medicine who is in charge of health, safety and medicine. The positive and negative shapes combine the two together, and the outer contour is similar to a bowl.

The healthy AKSOPEEK material is widely used in the medical industry to better serve the public, implying that patients regain their health, receive the blessing of the goddess, and continue to live a good life.

 

Product range

At present, our AKSOPEEK series products mainly include AKSOPEEK (pure material), AKSOPEEK HA (active enhanced modification), AKSOPEEK LF (long fiber modified reinforcement) and AKSOPEEK CF (chopped carbon fiber modified reinforcement) implant-grade materials.

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Changzhou Junhua Medical Technology Co., Ltd.

Changzhou Junhua Medical mainly deals in implant-grade PEEK, medical carbon fiber reinforced PEEK, PPSU, PEI and other medical polymer materials. With 17 years of experience in the application and development of polymer materials such as PEEK, the company has passed the ISO13485 quality system certification and has 1,200 square meters of Class 10,000 and Class 100,000 clean workshops, which can provide customers with one-stop services from raw material procurement to product OEM.

 


Tags: Company News

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