TRANS1 FACET SCREW


Device Classification Name

system, facet screw spinal device

510(k) Number K073515
Device Name TRANS1 FACET SCREW
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
Classification Product Code
MRW  
Date Received 12/14/2007
Decision Date 03/11/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No