FDA 510(k) Application Details - K163034

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K163034
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Smith and Nephew, Inc. 150 Minuteman Road Andover, MA 01810 US Other 510(k) Applications for this Company
Contact	Anne-Marie Keefe 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	10/31/2016
Decision Date	12/07/2016
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