FDA 510(k) Application Details - K231704

Device Classification Name	More FDA Info for this Device
510(K) Number	K231704
Device Name	Pro-Link« & Pro-Link« Ti Barbs Cervical Spacer 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	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2023
Decision Date	10/19/2023
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