FDA 510(k) Application Details - K181296

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K181296
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	Syntec Scientific Corporation No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang Chang Hua 50971 TW Other 510(k) Applications for this Company
Contact	Nicole Tseng Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2018
Decision Date	04/11/2019
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