FDA 510(k) Application Details - K080398

Device Classification Name	More FDA Info for this Device
510(K) Number	K080398
Device Name	SI JOINT FUSION SYSTEM
Applicant	SI-BONE, INC. 15370 PEPPER LANE SARATOGA, CA 95070 US Other 510(k) Applications for this Company
Contact	JEFFERY DUNN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2008
Decision Date	11/26/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review