VIP ANTERIOR CERVICAL PLATE SYSTEM


Device Classification Name

appliance, fixation, spinal intervertebral body

510(k) Number K081391
Device Name VIP ANTERIOR CERVICAL PLATE SYSTEM
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 888.3060
Classification Product Code
KWQ  
Date Received 05/19/2008
Decision Date 07/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No