FDA 510(k) Application Details - K182264

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K182264
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	ICONN Orthopedics, LLC 400 Union Hill Drive, Suite 150 Birmingham, AL 35209 US Other 510(k) Applications for this Company
Contact	Whitt Israel Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2018
Decision Date	10/19/2018
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