FDA 510(k) Application Details - K223708

Device Classification Name	More FDA Info for this Device
510(K) Number	K223708
Device Name	Entasis 3D Dual-Lead Sacroiliac Implant System
Applicant	CoreLink, LLC 2072 Fenton Logistics Park 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	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2022
Decision Date	03/21/2023
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