Zsfab, Inc. - FDA 510(k) Cleared Devices

Zsfab, Inc. develops patient-specific spinal implants using advanced design and digitally structured materials. The company is based in Cambridge with a focus on personalized orthopedic solutions for spine surgery.

Zsfab has received 5 FDA 510(k) clearances from 5 total submissions since its first clearance in 2021. The company specializes exclusively in orthopedic devices, with recent cleared products including cervical and lumbar interbody systems. Latest clearance activity in 2026 confirms the company remains actively engaged in regulatory submissions.

Zsfab's implant design emphasizes reliable bone integration, stress shielding reduction, and postoperative imaging clarity. The company integrates advanced planning tools, proprietary algorithms, and surgeon input to align implant structure with patient anatomy and biomechanics.

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

Regulatory submissions have been managed by Backroads Consulting, Inc. and Applied Technical Services (Empirical Technologies).