Stryker GmbH - FDA 510(k) Cleared Devices

Stryker GmbH, is a medical device manufacturer based in Selzach, Solothurn, Switzerland. The company specializes in orthopedic surgical devices and implants.

Stryker GmbH has received 54 FDA 510(k) clearances from 54 total submissions since 2015. The company's regulatory portfolio is entirely focused on orthopedic devices, reflecting its core expertise in fracture fixation and surgical instrumentation. The latest clearance was granted in 2026, demonstrating continued active development and market engagement.

Recent cleared devices include femur and humerus nailing systems, distal radius plating systems, and the Pangea Platform-a comprehensive modular plating system for multiple anatomical sites. The company also markets the Hoffmann LRF System and Gamma4 System for orthopedic trauma and reconstruction.

Explore the complete list of device names, product codes, and clearance dates in the database to review Stryker GmbH's full regulatory history.

510(k) submissions have been managed by Stryker GmbH as regulatory consultant.