TRANS1 AXIALIF SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K050965
Device Name TRANS1 AXIALIF SYSTEM
Applicant
TRANS1 INCORPORATED
1800 sir tyler drive
suite 101
wilmington, 
NC 
28405

Applicant Contact robert l sheridan
Correspondent
TRANS1 INCORPORATED
1800 sir tyler drive
suite 101
wilmington, 
NC 
28405

Correspodent Contact robert l sheridan
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 04/18/2005
Decision Date 06/14/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No