FDA 510(k) Application Details - K140925

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K140925
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	ACUMED, LLC 5885 NW CORNELIUS PASS ROAD HILLSBORO, OR 97124 US Other 510(k) Applications for this Company
Contact	LINO TSAI 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	04/11/2014
Decision Date	05/20/2014
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