Medical Device Manufacturer · US , Wilmington , NC

Trans1 Incorporated - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2005

Recent clearances: TRANS1 INTERBODY FUSION SYSTEM, TRANS1 AXIALIF PLUS, TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Trans1 Incorporated Orthopedic ✕

9 devices

1-9 of 9

Cleared Aug 23, 2012

TRANS1 INTERBODY FUSION SYSTEM

Orthopedic · 143d

Cleared Mar 14, 2011

TRANS1 AXIALIF PLUS

Orthopedic · 209d

Cleared Aug 26, 2010

TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T

Orthopedic · 213d

Cleared Jan 21, 2010

AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II

Orthopedic · 190d

Cleared Apr 28, 2008

TRANS1 AXIALIF 2-LEVEL OR II SYSTEM

Orthopedic · 124d

Cleared Mar 11, 2008

TRANS1 FACET SCREW

Orthopedic · 88d

Cleared Jan 11, 2008

TRANS1 AXIAL FIXATON SYSTEM

Orthopedic · 28d

Cleared Sep 26, 2005

TRANS1 FACET SCREWS

Orthopedic · 80d

Cleared Jun 14, 2005

TRANS1 AXIALIF SYSTEM

Orthopedic · 57d