August 25, 2020

Pressrelease:First 3D printed HAnano Surface® modified implant gets FDA approval

Promimic AB, the world’s leading innovator in nano surface modification, is pleased to announce the recent Innovasis, Inc. special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the first spinal interbody devices modified with HAnano Surface.

This was the first special 510(k) FDA approval of a device with HAnano Surface, meaning that since the regulatory pathway is established, an expedited regulatory process can occur. This also marks the first approval of a 3D printed porous titanium implant modified with HAnano Surface.

Pressrelease, in English (full version)
Pressrelease, in Swedish (full version)