ARDIS SPACER


Device Classification Name

intervertebral fusion device with bone graft, lumbar

510(k) Number K073202
Device Name ARDIS SPACER
Applicant
ABBOTT SPINE, INC.
5301 riata park ct., bldg f
austin, 
TX 
78727

Applicant Contact maritza elias
Correspondent
ABBOTT SPINE, INC.
5301 riata park ct., bldg f
austin, 
TX 
78727

Correspodent Contact maritza elias
Regulation Number 888.3080
Classification Product Code
MAX  
Date Received 11/13/2007
Decision Date 01/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls