Medical Device Manufacturer · US , Alachua , FL

Amend Surgical, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2017

Recent clearances: 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

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

1 devices

1-1 of 1

Cleared Feb 16, 2017

0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

Orthopedic · 212d

Data Source

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

Last updated: Sep 24, 2026