SI-LOK SACROILIAC JOINT FIXATION SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K112028
Device Name SI-LOK SACROILIAC JOINT FIXATION SYSTEM
Applicant
GLOBUS MEDICAL, INC.
2560 general armistead ave.
valley forge business center
audubon, 
PA 
19403

Applicant Contact wendy s hills
Correspondent
GLOBUS MEDICAL, INC.
2560 general armistead ave.
valley forge business center
audubon, 
PA 
19403

Correspodent Contact wendy s hills
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
OUR  
Date Received 07/15/2011
Decision Date 12/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No