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About

About US

Fix N Fuse Medical Kft. is a Hungarian-owned business that was established in 2020 with its headquarters in Hungary. The company's main activity is scientific and technical research and development, specifically in the field of medical device development, manufacturing, and trading. Our team members have decades of experience in developing, manufacturing, and operating quality management systems for medical devices. Our company has a close professional relationship with the leading spine surgeons in Hungary, who have significantly contributed to the development of Fix N Fuse Medical's spine implants. Our products are intervertebral fusion implants made from a biocompatible titanium alloy using the latest 3D printing technology and used in bone fusion procedures in spine surgery. Our implants have undergone conformity assessment procedures as required by European and Hungarian regulations, which we have successfully certified. Therefore, our products are labeled with the CE mark and can be sold in the European Union.

As a newly established company, our primary goal is to earn the trust of our customers and maintain their satisfaction. Fix N Fuse Medical Kft.'s intervertebral fusion implants are made using the most innovative manufacturing technology of our time. We hope that by offering our high-quality products at a reasonable price, we can contribute to the healing of more and more people. As a Hungarian manufacturer, it is a particular pleasure for us to be able to provide our products to the Hungarian healthcare system.

news

News

Succesful CE and ISO 13485 Certification

12.05.2021.

Fix N Fuse Medical Kft. has demonstrated, for the first time during the initial audit, that its quality management system meets the requirements of the EN ISO 13485:2016 standard. Additionally, the conformity assessment procedure for Fix N Fuse Spinal System implants was carried out and accepted by our Notified body, NEOEMKI National Medical Device Conformity Assessment and Certification Ltd., through preliminary documentation review and subsequent audit, resulting in the issuance of an EC certificate. This enables us to affix the CE mark on our products, which can be placed on the market within the European Union.

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