TRANS1 AXIALIF 2-LEVEL OR II SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K073643
Device Name TRANS1 AXIALIF 2-LEVEL OR II SYSTEM
Applicant
TRANS1 INCORPORATED
411 landmark dr.
wilmington, 
NC 
28412

Applicant Contact robert sheridan
Correspondent
TRANS1 INCORPORATED
411 landmark dr.
wilmington, 
NC 
28412

Correspodent Contact robert sheridan
Regulation Number 888.3060
Classification Product Code
KWQ  
Date Received 12/26/2007
Decision Date 04/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No