IFUSE IMPLANT SYSTEM


Device Classification Name

sacroiliac joint fixation

510(k) Number K110838
Device Name IFUSE IMPLANT SYSTEM
Applicant
SI-BONE, INC.
1835 market street
29th floor
philadelphia, 
PA 
19103

Applicant Contact janice m hogan
Correspondent
SI-BONE, INC.
1835 market street
29th floor
philadelphia, 
PA 
19103

Correspodent Contact janice m hogan
Regulation Number 888.3040
Classification Product Code
OUR  
Date Received 03/25/2011
Decision Date 04/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No