FDA 510(k) Application Details - K110838

Device Classification Name	More FDA Info for this Device
510(K) Number	K110838
Device Name	IFUSE IMPLANT SYSTEM
Applicant	SI-BONE, INC. 1835 MARKET STREET 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE M HOGAN 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	03/25/2011
Decision Date	04/21/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review