NIKO CORPECTOMY SPACER


Device Classification Name

spinal vertebral body replacement device

510(k) Number K072465
Device Name NIKO CORPECTOMY 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 888.3060
Classification Product Code
MQP  
Date Received 09/04/2007
Decision Date 10/04/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No