Silony Medical GmbH - FDA 510(k) Cleared Devices

Silony Medical GmbH, is a spine surgery device manufacturer specializing in spinal fusion hardware and surgical systems. Founded in 2013 by the Schön Clinic hospital group, the company operates with a manufacturing facility in Leinfelden-Echterdingen, Germany, and maintains a global presence across 20+ countries.

The company has received 12 FDA 510(k) clearances from 12 total submissions, with all submissions focused on Orthopedic devices. Silony's regulatory track record spans from 2017 to 2026, demonstrating sustained innovation and market engagement in spinal implant technology.

The company's product portfolio centers on modular spinal fixation systems, interbody cages, and navigation instruments designed to enable surgeon flexibility and procedural choice. Key product lines include posterior fixation systems, anterior and lateral fusion cages, and integrated navigation platforms for minimally invasive spine surgery.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

Regulatory submissions have been managed by Empirical Testing Corp, Mcra, LLC and Empirical Technologies.