FDA 510(k) Application Details - K200087

Device Classification Name	More FDA Info for this Device
510(K) Number	K200087
Device Name	F3D Cervical Stand-Alone Interbody Fusion System
Applicant	CoreLink, LLC 2072 Fenton Logistics Park Blvd. St. Louis, MO 63206 US Other 510(k) Applications for this Company
Contact	Steven Mounts 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	01/15/2020
Decision Date	06/15/2020
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