SI JOINT FUSION SYSTEM


Device Classification Name

sacroiliac joint fixation

510(k) Number K080398
Device Name SI JOINT FUSION SYSTEM
Applicant
SI-BONE, INC.
15370 pepper lane
saratoga, 
CA 
95070

Applicant Contact jeffery dunn
Correspondent
SI-BONE, INC.
15370 pepper lane
saratoga, 
CA 
95070

Correspodent Contact jeffery dunn
Regulation Number 888.3040
Classification Product Code
OUR  
Date Received 02/13/2008
Decision Date 11/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No