PATRIOT SPACERS: COLONIAL ACDF


Device Classification Name

intervertebral fusion device with bone graft, cervical

510(k) Number K072991
Device Name PATRIOT SPACERS: COLONIAL ACDF
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
ODP  
Date Received 10/23/2007
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