FDA 510(k) Application Details - K170482

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K170482
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	TASARIMMED TIBBI MAMULLER SANAYI VE TICARET A.S Demirkapi Topcular Mahallesi Topcular Caddesi Set Ustu No:3 Istanbul TR 34055 TR Other 510(k) Applications for this Company
Contact	Sumru Alperen 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	02/16/2017
Decision Date	09/27/2017
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