Medical Device Manufacturer · US , Woburn , MA

Bio2 Technologies, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2014

Recent clearances: Bio2 CLM BG Bioactive Scaffold, Bio2 Fusion Implant System, Bio2 CLM BG Bioactive Scaffold

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bio2 Technologies, Inc. Orthopedic ✕

3 devices

1-3 of 3

Cleared Jan 12, 2016

Bio2 CLM BG Bioactive Scaffold

Orthopedic · 124d

Cleared Dec 30, 2015

Bio2 Fusion Implant System

Orthopedic · 174d

Cleared Dec 18, 2014

Bio2 CLM BG Bioactive Scaffold

Orthopedic · 107d

Data Source

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

Last updated: Sep 21, 2026