Medical Device Manufacturer · US , Apple Valley , MN

Eden Spine, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2012

Recent clearances: Sphynx™, GIZA(R) VERTEBRAL BODY REPLACEMENT

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Eden Spine, LLC Orthopedic ✕

2 devices

1-2 of 2

Cleared Dec 22, 2016

Orthopedic · 259d

Cleared Jan 26, 2012

GIZA(R) VERTEBRAL BODY REPLACEMENT

Orthopedic · 156d

Data Source

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

Last updated: Sep 16, 2026