FDA 510(k) Application Details - K182919

Device Classification Name	More FDA Info for this Device
510(K) Number	K182919
Device Name	SI-Restore« Sacroiliac Joint Fixation System
Applicant	Biofusion Medical 2503 Cedarview Drive Austin, TX 78704 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	10/19/2018
Decision Date	01/25/2019
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