FDA 510(k) Application Details - K172183

Device Classification Name	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis   More FDA Info for this Device
510(K) Number	K172183
Device Name	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Applicant	Orthofix Srl Via Delle Nazioni 9 Bussolengo 37012 IT Other 510(k) Applications for this Company
Contact	Gianluca Ricadona Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	OBT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2017
Decision Date	01/09/2018
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