TRANSITION STABILIZATION SYSTEM


Device Classification Name

posterior metal/polymer spinal system, fusion

510(k) Number K073439
Device Name TRANSITION STABILIZATION SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

Applicant Contact kelly j baker
Correspondent
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

Correspodent Contact kelly j baker
Regulation Number 888.3070
Classification Product Code
NQP  
Date Received 12/07/2007
Decision Date 02/20/2009
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No