Medical Device Manufacturer · US , New York , NY

Small Bone Innovations, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005

Recent clearances: SBI AUTOFIX, SBI WRISTFIT, SBI K-WIRES

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Small Bone Innovations, LLC Orthopedic ✕

4 devices

1-4 of 4

Cleared Nov 07, 2005

Orthopedic · 49d

Cleared Sep 06, 2005

Orthopedic · 69d

Cleared Aug 10, 2005

Orthopedic · 55d

Cleared Apr 26, 2005

SBI HAND FIXATION SYSTEM (TM)

Orthopedic · 62d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 26, 2026