FDA 510(k) Application Details - K181118

Device Classification Name	More FDA Info for this Device
510(K) Number	K181118
Device Name	Reliance Lumbar IBF System
Applicant	Reliance Medical Systems 545 West 500 South Suite 100 Bountiful, UT 84010 US Other 510(k) Applications for this Company
Contact	Bret M Berry Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2018
Decision Date	01/09/2019
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