FDA 510(k) Application Details - K181540

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K181540
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	CITIEFFE S.r.L. Via Armaroli, 21 Calderara di Reno 40012 IT Other 510(k) Applications for this Company
Contact	Stefano Pullega 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	06/11/2018
Decision Date	01/16/2019
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