FDA 510(k) Application Details - K180749

Device Classification Name	More FDA Info for this Device
510(K) Number	K180749
Device Name	Life Spine SIMPACT Sacroiliac Joint Fixation System
Applicant	Life Spine Inc. 13951 S Quality Drive Huntley, IL 60142 US Other 510(k) Applications for this Company
Contact	Randy Lewis 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	03/22/2018
Decision Date	06/15/2018
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