MEDTRONIC SOFAMOR DANEK USA, INC.

FDA-Registered Company Profile for MEDTRONIC SOFAMOR DANEK USA, INC.

FDA-Supplied Establishment Information:

Establishment Registration Number:

3003120897

Company Name:

MEDTRONIC SOFAMOR DANEK USA, INC.

Also Known As:

DANEK
DANEK MEDICAL, INC.
MEDTRONIC
MEDTRONIC SOFAMOR DANEK, INC.
MEDTRONIC SOFAMOR DANEK
SOFAMOR DANEK USA,INC.
SOFAMOR DANEK
SOFAMOR DANEK GROUP, INC.
SOFAMOR
TIMESH

Address:

4340 SWINNEA RD.

Address 2:

City:

MEMPHIS

State

Zip / Postal Code:

38118

County:

SHELBY

Country:

Establishment Operation Code(s):

AA - Initial Distributor
MM - Manufacturer
RR - Repackager/Relabeller

Establishment Status Code:

A - Active

Year of Most Recent Initial
or Annual Registration:

2007

FDA-Supplied Owner/Operator Information:

Owner/Operator Number:

2112641

Company Name:

MEDTRONIC INC.

Address:

710 MEDTRONIC PKWY.

Address 2:

City:

MINNEAPOLIS

State:

Zip / Postal Code:

55432

Country:

Owner/Operator Phone:

763-514-4000

FDA-Supplied Official Correspondent Information:

Official Correspondent Name:

MR. PAUL ELLIOTT

Company Name:

MEDTRONIC SOFAMOR DANEK USA, INC.

Address:

1800 PYRAMID PLACE

Address 2:

City:

MEMPHIS

State:

Zip / Postal Code:

38132

Country:

Official Corespondent Phone Number:

901-396-3133 4668

Other Establishment Information:

Establishment Phone:

Fax:

General Email:

Web Site:

Company Brochure:

Keywords:

Company Description:

Services Offered:

About Us:

Differentiation:

FDA-Registered Products Offered by MEDTRONIC SOFAMOR DANEK USA, INC.
	Common Device Name	Proprietary Device Name
1	ANTERIOR FIXATION DEVICES	MULTIPLE, TSRH, CD HORIZON, DYNALOK, ATLANTIS, ZPLATE-ATL, PYRAMID, VERTE-STACK
2	ARTHROSCOPE	ARTHROSCOPE
3	AWL	MULTIPLE PRODUCT NAMES
4	BONE SCREW	SCREW, FIXATION, BONE
5	BONE VOID FILLER MATERIAL	BIPHASIC CALCIUM BONE VOID FILLER (BCP)
6	BONE, VOID FILLER	MASTERGRAFT (TM) BONE VOID FILLER
7	CASE/TRAY	MULTIPLE PRODUCT NAMES
8	CEMENT RESTRICTOR	TCR, PCR, SHADOW CR, THREADED CR
9	CEMENT, BONE, VERTEBROPLASTY	CEMENT, BONE, VERTEBROPLASTY
10	COLLAGEN SPONGE	INFUSE BONE GRAFT
11	COLLAGEN SPONGE	INFUSE BONE GRAFT
12	COUNTERSINK	COUNTERSINK
13	DISPENSER, CEMENT	DISPENSER, CEMENT
14	FORK, FORK HAMMER	MULTIPLE PRODUCT NAMES
15	GENERAL PURPOSE CENTRIFUGE	MAGELLAN AUTOLOGOUS PLATELET SEPARATOR SYSTEM
16	HOLDER, NEEDLE	HOLDER NEEDLE; ORTHOPEDIC (ORTHOPEDIC MANUAL SURGICAL INST)
17	IMPACTOR	MULTIPLE PRODUCT NAMES
18	INTERLAMINAL CLAMP	APOFIX
19	INTERVERTEBRAL DISC PROSTHESIS	BRYAN TOTAL CERVICAL DISC,PRESTIGE CERVICAL DISC,MAVERICK TOTAL DISC REPLACEMENT
20	METALLIC BONE FIXATION DEVICE	TSRH SPINAL SYSTEM, CD HORIZON SPINAL SYSTEM
21	MICROSURGICAL, INSTRUMENTS	MICRO-ENDO SYSTEMS
22	MONOPOLAR STIMULATING INSTRUMENTATION	MULTIPLE PRODUCT NAMES
23	MONOPOLAR STIMULATING INSTRUMENTATION	MULTIPLE PRODUCT NAMES
24	MONOPOLAR STIMULATING INSTRUMENTATION	MULTIPLE PRODUCT NAMES
25	MUELLER	MUELLER TYPE
26	MULTI-AXIAL SCREW	ALPHA POSTERIOR SPINAL SYSTEM
27	MULTIPLE (BONE PLATES)	MULTIPLE (BONE PLATES)
28	MULTIPLE (CHISELS & OSTEOTOMES)	MULTIPLE (CHISELS & OSTEOTOMES)
29	MULTIPLE (DEPTH GAUGES)	MULTIPLE (DEPTH GAUGES)
30	MULTIPLE (DRIVER-EXTRACTORS)	MULTIPLE (DRIVER-EXTRACTORS)
31	MULTIPLE (ORTHOPEDIC CLAMPS)	MULTIPLE (ORTHOPEDIC CLAMPS)
32	MULTIPLE (ORTHOPEDIC CURETTES)	MULTIPLE (ORTHOPEDIC CURETTES)
33	MULTIPLE (ORTHOPEDIC OSTEOTOMES)	MULTIPLE (ORTHOPEDIC OSTEOTOMES)
34	MULTIPLE (ORTHOPEDIC REAMERS)	MULTIPLE (ORTHOPEDIC REAMERS)
35	MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS)	MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS)
36	MULTIPLE (SCISSORS)	MULTIPLE (SCISSORS)
37	MULTIPLE (SURGICAL MALLETS)	MULTIPLE (SURGICAL MALLETS)
38	MULTIPLE ELEVATORS, ORTHOPEDIC	ELEVATOR, ORTHOPEDIC
39	MULTIPLE FORCEPS	MULTIPLE FORCEPS
40	MULTIPLE PLIERS, SURGICAL	PLIERS, SURGICAL
41	MULTIPLE RETRACTORS	RETRACTOR
42	MULTPLE TAMPS	MULTIPLE PRODUCT NAMES
43	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	MULTIPLE PRODUCT NAMES
44	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE	ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE
45	ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL	ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
46	PLATE AND SCREW COMPRESSION DEVICES	MULTIPLE PRODUCT NAMES
47	SCREWDRIVER, ORTHOPEDIC	MULTIPLE PRODUCT NAMES
48	SOCKET	MULTIPLE PRODUCT NAMES
49	SPINAL FUSION DEVICE	INTERFIX TM THREADED FUSION DEVICE
50	SURGICAL LAMP	SURGICAL LAMP
51	SYNTHETIC BONE SUBSTITUTE	BCP BICALPHOS
52	TEMPLATE	TEMPLATE
53	THOMPSON	THOMPSON TYPE
54	VARIOUS (RONGEURS)	MULTIPLE (RONGEURS)
55	VARIOUS BENDERS	MULTIPLE PRODUCT NAMES
56	VARIOUS ELECTROSURGICAL ACCESSORIES	MULTIPLE ELECTROSURGICAL ACCESSORIES
57	VARIOUS RASPS	MULTIPLE (ORTHOPEDIC RASPS)
58	VARIOUS ROD BENDERS	ROD BENDER
59	VARIOUS RONGEURS	RONGEUR
60	VARIOUS SIZES OF SURGICAL PILLOWS	INFLATABLE SURGICAL PILLOWS
61	VARIOUS SURGICAL BURS	MULTIPLE PRODUCT NAMES
62	VARIOUS SURGICAL DRILLS	MULTIPLE PRODUCT NAMES
63	VARIOUS TENSION CRIMPER	MULTIPLE PRODUCT NAMES
64	VARIOUS TWIST, BIT DRILLS	MULTIPLE TWIST, BIT DRILLS
65	VARIOUS TYPES OF DRILL GUIDES & GUIDE WIRES (PINS)	DRILL GUIDES & GUIDE WIRES (PINS)
66	VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS	MULTIPLE PRODUCT NAMES
67	VARIOUS TYPES OF ORTHOPEDIC WRENCHES	MULTIPLE PRODUCT NAMES
All FDA-Registered products for this company are displayed above.

Other Products Offered by MEDTRONIC SOFAMOR DANEK USA, INC.:

No products have been listed by this company.

Services Offered by the MEDTRONIC SOFAMOR DANEK USA, INC.:
No services have been listed by this company.

Additional Contact Information for MEDTRONIC SOFAMOR DANEK USA, INC.:
There is no additional contact information for this company.

Companies Related to MEDTRONIC SOFAMOR DANEK USA, INC.

Our records indicate that the following companies are related by ownership.

	Company Name	Address	City	State	Zip	Country
1	MEDTRONIC B.V.	EARL BAKKENSTRAAT 10	6422 PJ HEERLEN		6422 PJ	NL
2	MEDTRONIC BLOOD MANAGEMENT	18501 EAST PLAZA DR.	PARKER	CO	80134	US
3	MEDTRONIC CARDIAC SURGERY TECHNOLOGIES	7601 NORTHLAND DR.	MINNEAPOLIS	MN	55428	US
4	MEDTRONIC FABRICATION S.A.S.	103 ROUTE D'ANOR	FOURMIES		59610	FR
5	MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT	7000 CENTRAL AVE. N.E.	MINNEAPOLIS	MN	55432	US
6	MEDTRONIC IRELAND	PARKMORE BUSINESS PARK WEST	GALWAY			EI
7	MEDTRONIC MEXICO EG	CARRETERA INTL. KM. 1969 GUADALAJARA-NOGALES KM.2	EMPALME, SONORA		85340	MX
8	MEDTRONIC MEXICO, S. DE R.L. DE C.V.	AVENIDA PASEO DEL CUCAPAH10510 PARQUE INDUSTRIAL EL LAGO	TIJUANA, B.C.		22570	MX
9	MEDTRONIC NAVIGATION ISRAEL, LTD.	1 HAMELAHA STREET, KOHAV YOKNEAM	YOKNEAM ELIT		20692	IS
10	MEDTRONIC NAVIGATION, INC.	826 COAL CREEK CIR.	LOUISVILLE	CO	80027	US
11	MEDTRONIC NAVIGATION, INC. (LITTLETON)	300 FOSTER STREET	LITTLETON	MA	01460	US
12	MEDTRONIC NEUROMODULATION	800 53RD AVE., N.E.	MINNEAPOLIS	MN	55421	US
13	MEDTRONIC NEUROSURGERY	125 CREMONA DR.	GOLETA	CA	93117	US
14	MEDTRONIC PERFUSION SYSTEMS	7611 NORTHLAND DR.	MINNEAPOLIS	MN	55432	US
15	MEDTRONIC POWERED SURGICAL SOLUTIONS	4620 NORTH BEACH ST.	FORT WORTH	TX	76137	US
16	MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS	ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK	JUNCOS	PR	00777	US
17	MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA	RD. 149, KM. 56.3 CALL BOX 6001	VILLALBA	PR	00766	US
18	MEDTRONIC PUERTO RICO OPERATIONS CO.,MED REL	ROAD 909, KM. 0.4. BARRIO MARIANA	HUMACAO	PR	00792	US
19	MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH	WERFTSTRASSE 17	DEGGENDORF		94469	GM
20	MEDTRONIC SOFAMOR DANEK USA, INC.	1800 PYRAMID PLACE	MEMPHIS	TN	38132	US
21	MEDTRONIC SWISS MANUFACTURING FACILITY	ROUTE DU MOLLIAU 31	TOLOCHENAZ		1131	SZ
22	MEDTRONIC VASCULAR	35-37A CHERRY HILL DR	DANVERS	MA	01923	US
23	MEDTRONIC VASCULAR	3576 UNOCAL PL.	SANTA ROSA	CA	95403	US
24	MEDTRONIC XOMED INSTRUMENTATION S.A.S.	RUE LE PAVILLON SAINT AUBIN LE MONIAL	BOURBON L'ARCHAMBAULT		03160	FR
25	MEDTRONIC XOMED, INC.	6743 SOUTHPOINT DR. NORTH	JACKSONVILLE	FL	32216	US
26	MEDTRONIC XOMED, INC.	950 FLANDERS RD.	MYSTIC	CT	06355	US
27	THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG	1851 EAST DEERE AVE.	SANTA ANA	CA	92705	US
28	WARSAW ORTHOPEDIC, INC.	2500 SILVEUS CROSSING	WARSAW	IN	46582	US

FDA-Registered Company Profile for MEDTRONIC SOFAMOR DANEK USA, INC.

FDA-Registered Products Offered by MEDTRONIC SOFAMOR DANEK USA, INC.

Other Products Offered by MEDTRONIC SOFAMOR DANEK USA, INC.:

Services Offered by the MEDTRONIC SOFAMOR DANEK USA, INC.:

Additional Contact Information for MEDTRONIC SOFAMOR DANEK USA, INC.:

Companies Related to MEDTRONIC SOFAMOR DANEK USA, INC.