FDA 510(k) Application Details - K201538

Device Classification Name	More FDA Info for this Device
510(K) Number	K201538
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	Angela Batker 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	06/09/2020
Decision Date	09/18/2020
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