ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM


Device Classification Name

appliance, fixation, spinal interlaminal

510(k) Number K110963
Device Name ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
Applicant
GLOBUS MEDICAL INC.
2560 general armistead ave.
audubon, 
PA 
19403

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

Correspodent Contact kelly j baker, ph.d
Regulation Number 888.3050
Classification Product Code
KWP  
Date Received 04/06/2011
Decision Date 05/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No