FDA 510(k) Application Details - K180814

Device Classification Name	More FDA Info for this Device
510(K) Number	K180814
Device Name	CoreLink« M3Ö Stand-Alone Anterior Lumbar System
Applicant	CoreLink, LLC 7911 Forsyth Blvd., Suite 200 St. Louis, MO 63105 US Other 510(k) Applications for this Company
Contact	Steve Mounts 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	03/29/2018
Decision Date	08/10/2018
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