FDA 510(k) Application Details - K172612

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K172612
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Arthex, Inc 1370 Creekside Boulevard Naples, FL 34108 US Other 510(k) Applications for this Company
Contact	Ivette Galmez 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	08/31/2017
Decision Date	09/28/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review