Medical Device Manufacturer · US , Westlake , OH

Spinal Edge, LLC - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2006

Recent clearances: ATLAS INTERVERTEBRAL BODY CAGE, SPINAL EDGE TITAN PEDICLE SCREW SYSTEM, ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spinal Edge, LLC Orthopedic ✕

3 devices

1-3 of 3

Cleared Feb 02, 2010

ATLAS INTERVERTEBRAL BODY CAGE

Orthopedic · 146d

Cleared Jul 24, 2009

SPINAL EDGE TITAN PEDICLE SCREW SYSTEM

Orthopedic · 98d

Cleared Jun 08, 2006

ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.

Orthopedic · 65d