FDA 510(k) Application Details - K200868

Device Classification Name	More FDA Info for this Device
510(K) Number	K200868
Device Name	SI-Restore Sacroiliac Joint Fixation System
Applicant	Biofusion Medical 2101 E St Elmo Rd, Building 1, Suite 100, PMB-1, Office 231 Austin, TX 74744 US Other 510(k) Applications for this Company
Contact	Rylan Reed 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	04/01/2020
Decision Date	04/17/2020
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