FDA 510(k) Application Details - K191148

Device Classification Name	More FDA Info for this Device
510(K) Number	K191148
Device Name	Medtronic HV-RÖ Bone Cement, KyphonÖ XpedeÖ Bone Cement, CD HorizonÖ Fenestrated Screw Set
Applicant	Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 US Other 510(k) Applications for this Company
Contact	Shweta Sharma Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2019
Decision Date	09/12/2019
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