FDA 510(k) Application Details - K163486

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K163486
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	HNM Total Recon, LLC 20855 NE 16th Ave Suite C15 Miami, FL 33179 US Other 510(k) Applications for this Company
Contact	Noah Roitman Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2016
Decision Date	07/24/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review