SOVEREIGN SPINAL SYSTEM


Device Classification Name

intervertebral fusion device with integrated fixation, lumbar

510(k) Number K110063
Device Name SOVEREIGN SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact mike scott
Correspondent
MEDTRONIC SOFAMOR DANEK, INC.
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact mike scott
Regulation Number 888.3080
Classification Product Code
OVD  
Date Received 01/10/2011
Decision Date 10/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No