FDA 510(k) Application Details - K182285

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component   More FDA Info for this Device
510(K) Number	K182285
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant	Paonan Biotech Co., Ltd. 3F, No. 50, Lane. 258, Rueiguang Road., Neihu District Taiwan, R.O.C. Taipei City 11491 TW Other 510(k) Applications for this Company
Contact	Vivi Tsai Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2018
Decision Date	06/20/2019
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