SI-FIX SACROILIAC JOINT FUSION SYSTEM


Device Classification Name

sacroiliac joint fixation

510(k) Number K110472
Device Name SI-FIX SACROILIAC JOINT FUSION SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Applicant Contact lee grant
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis, 
TN 
38132

Correspodent Contact lee grant
Regulation Number 888.3040
Classification Product Code
OUR  
Date Received 02/18/2011
Decision Date 05/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No