FDA 510(k) Application Details - K241464

Device Classification Name	More FDA Info for this Device
510(K) Number	K241464
Device Name	ARx« SAI Implant System
Applicant	Life Spine, Inc. 13951 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	05/23/2024
Decision Date	07/29/2024
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