FDA 510(k) Application Details - K211417

Device Classification Name	More FDA Info for this Device
510(K) Number	K211417
Device Name	F3D-C2 Cervical Stand-Alone System
Applicant	CoreLink, LLC 2072 Fenton Logistics Blvd. St. Louis, MO 63026 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	05/07/2021
Decision Date	02/04/2022
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