FDA 510(k) Application Details - K131636

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite   More FDA Info for this Device
510(K) Number	K131636
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant	ACUMED LLC 5885 NW CORNELIUS PASS RD. HILLSBORO, OR 97124-9432 US Other 510(k) Applications for this Company
Contact	BRITTANY CUNNINGHAM Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	LXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2013
Decision Date	10/10/2013
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