FDA 510(k) Application Details - K152237

Device Classification Name	More FDA Info for this Device
510(K) Number	K152237
Device Name	The Entasis Dual-Lead Sacroiliac Implant
Applicant	CoreLink, LLC 7606 Forsyth Blvd St.Louis, MO 63105 US Other 510(k) Applications for this Company
Contact	Dan Hoehn 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	08/10/2015
Decision Date	02/04/2016
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