PATRIOT SPACERS


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K072970
Device Name PATRIOT SPACERS
Applicant
GLOBUS MEDICAL, INC.
2560 general armistead ave.
valley forge business center
audubon, 
PA 
19403

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

Correspodent Contact kelly j baker
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 10/22/2007
Decision Date 01/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No