Device Listing 1406628358

Listing Summary#

Listing key: 1406628358
Premarket submission: K161210
Device: RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
Applicant: Medtronic Sofamor Danek
Product code: OUR
Decision date: 2016-08-12

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
5761	1030489	1000477302	MEDTRONIC SOFAMOR DANEK USA, INC.	1	Y	2026-01-01	1800 PYRAMID PLACE Memphis TN US 38132
5810	1824199	1824199	WARSAW ORTHOPEDIC, INC.	1	N	2027-01-01	2500 Silveus Xing WARSAW IN US 46582
5811	2647346	2647346	MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO	1	Y	2027-01-01	ROAD 909, KM. 0.4. BARRIO MARIANA HUMACAO PR US 00792
5762	3003120897	3003120897	MEDTRONIC SOFAMOR DANEK USA, INC.	1	N	2027-01-01	4340 Swinnea Road Memphis TN US 38118
277789	3014725904	3014725904	Michelle Obenauer	1	N	2027-01-01	Medtronic Sofamor Danek Headquarters 1800 Pyramid Place Memphis TN US 38132
312405	3018094310	3018094310	Medtronic Engineering and Innovation Center (MEIC)	1	N	2027-01-01	BSR Tech Park Survey No.135, 138, 141 & 142 Nanakramguda Main Hyderabad Telangana IN 500032