FDA 510(k) Application Details - K163181

Device Classification Name	More FDA Info for this Device
510(K) Number	K163181
Device Name	TRANSLACEÖ Spinal Tethering System
Applicant	Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 US Other 510(k) Applications for this Company
Contact	Becky Ronner Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2016
Decision Date	05/16/2017
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