FDA 510(k) Application Details - K183049

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K183049
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Reliance Medical Systems LLC 545 West 500 South Suite 100 Bountiful, UT 84010 US Other 510(k) Applications for this Company
Contact	Bret Berry Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2018
Decision Date	02/15/2019
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