TRANS1 AXIAL FIXATON SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K073514
Device Name TRANS1 AXIAL FIXATON SYSTEM
Applicant
TRANS1 INCORPORATED
411 landmark dr.
wilmington, 
NC 
28412

Applicant Contact william jackson
Correspondent
TRANS1 INCORPORATED
411 landmark dr.
wilmington, 
NC 
28412

Correspodent Contact william jackson
Regulation Number 888.3060
Classification Product Code
KWQ  
Subsequent Product Code
HRX  
Date Received 12/14/2007
Decision Date 01/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No