ARCHITEX SPACE MAINTENANCE SYSTEM


Device Classification Name

plate, bone

510(k) Number K110259
Device Name ARCHITEX SPACE MAINTENANCE SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact kelly davidson
Correspondent
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact kelly davidson
Regulation Number 872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZE  
Date Received 01/28/2011
Decision Date 04/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No