Medical Device Manufacturer · US , Cambridge , MA

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

5 submissions · 5 cleared · Since 2021

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Zsfab, Inc. Orthopedic ✕

5 devices

1-5 of 5

Regulatory consultants 510(k) submission support ecosystem

Backroads Consulting, Inc.

Applied Technical Services (Empirical Technologies)

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 14, 2026