INTERCONTINENTAL PLATE-SPACER


Device Classification Name

intervertebral fusion device with integrated fixation, lumbar

510(k) Number K103382
Device Name INTERCONTINENTAL PLATE-SPACER
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 888.3080
Classification Product Code
OVD  
Date Received 11/18/2010
Decision Date 05/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No