Medical Device Manufacturer · US , Excelsior , MN

Trans1, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2004

Recent clearances: TRANS1LATERAL INTERBODY FUSION SYSTEM, TRANS1 AXIAL FIXATION SYSTEM, TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Trans1, Inc. Orthopedic ✕

3 devices

1-3 of 3

Cleared Apr 01, 2013

TRANS1LATERAL INTERBODY FUSION SYSTEM

Orthopedic · 96d

Cleared Dec 17, 2004

TRANS1 AXIAL FIXATION SYSTEM

Orthopedic · 302d

Cleared Jan 15, 2004

TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT

Orthopedic · 120d