|
FDA-Registered Company Profile for WARSAW ORTHOPEDIC, INC.
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| FDA-Supplied Establishment Information: |
|
| Establishment Registration Number: |
1824199 |
| Company Name: |
WARSAW ORTHOPEDIC, INC. |
| Also Known As: |
MEDTRONIC SOFAMOR DANEK
MEDTRONIC SOFAMOR DANEK GROUP, INC.
MEDTRONIC SOFAMOR DANEK USA, INC.
MEDTRONIC SOFAMOR DANEK MFG., INC.
|
| Address: |
2500 SILVEUS CROSSING |
| Address 2: |
|
| City: |
WARSAW |
| State |
IN |
| Zip / Postal Code: |
46582 |
| County: |
|
| Country: |
US |
| Establishment Operation Code(s): |
ME - Contract Manufacturer
MM - Manufacturer
MR - Remanufacturer
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: |
MN |
| Zip / Postal Code: |
55432 |
| Country: |
US |
| 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: |
TN |
| Zip / Postal Code: |
38132 |
| Country: |
US |
| Official Corespondent Phone Number: |
901-396-3133 4668
|
 |
 |
| Other Establishment Information: |
| Establishment Phone: |
|
| Fax: |
|
| General Email: |
|
| Web Site: |
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| Company Brochure: |
|
| Keywords: |
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| Company Description: |
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| Services Offered: |
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| About Us: |
|
| Differentiation: |
|
FDA-Registered Products Offered by WARSAW ORTHOPEDIC, INC.
|
|
Common Device Name |
Proprietary Device Name |
| 1 |
AEROPLANE SPLINT |
AEROPLANE SPLINT |
| 2 |
ANTERIOR IMPLANT FIXATION DEVICES |
MULTIPLE PRODUCT NAMES |
| 3 |
ARTHROSCOPE |
ARTHROSCOPE |
| 4 |
ARTHROSCOPIC SYSTEM |
MULTIPLE PRODUCT NAMES |
| 5 |
AWL |
MULTIPLE PRODUCT NAMES |
| 6 |
AXIS, TIMESH, ATLAS |
AXIS, TIMESH, ATLAS |
| 7 |
BED BOARD |
BED BOARD |
| 8 |
BONE PLATE DEVICES |
MULTIPLE PRODUCT NAMES |
| 9 |
BONE SCREWS-STERILE AND NON-STERILE |
MULTIPLE PRODUCT NAMES |
| 10 |
BONE SKID |
MURPHY LANE BONE SKID |
| 11 |
BONE TAP |
BONE TAP |
| 12 |
BUR |
MULTIPLE PRODUCT NAMES |
| 13 |
CABLE |
SONGER CABLE SYSTEM |
| 14 |
CABLE DEVICES-STERILE AND NON-STERILE |
MULTIPLE PRODUCT NAMES |
| 15 |
CAMERA |
MULTIPLE PRODUCT NAMES |
| 16 |
CASE/TRAY |
MULTIPLE PRODUCT NAMES |
| 17 |
CAST BOOT |
CAST BOOT |
| 18 |
CEMENT RESTRICTOR |
TCR, PCR, SHADOW CR, THREADED CR |
| 19 |
CEMENT RESTRICTOR |
TCR, PCR, SHADOW CR, THREADED CR |
| 20 |
CERVICAL IMPLANT FIXATION DEVICE |
ORION ANTERIOR CERVICAL PLATE SYSTEM |
| 21 |
COUNTERSINK |
COUNTERSINK |
| 22 |
DISPENSER, CEMENT |
DISPENSER, CEMENT |
| 23 |
DRILL |
MULTIPLE PRODUCT NAMES |
| 24 |
DRILL BRACE |
DRILL BRACE |
| 25 |
FEMORAL NECK PUNCH |
FEMORAL NECK PUNCH |
| 26 |
FORK, FORK HAMMER |
MULTIPLE PRODUCT NAMES |
| 27 |
GENERAL PURPOSE CENTRIFUGE |
MAGELLAN AUTOLOGOUS PLATELET SEPARATOR SYSTEM |
| 28 |
HOLDER, NEEDLE |
MAYO-HEGAR NEEDLE HOLDER |
| 29 |
HOLDER, NEEDLE |
HOLDER, NEEDLE; ORTHOPEDIC (ORTHOPEDIC MANUAL SURGICAL INST) |
| 30 |
HOOK, SURGICAL |
BONE HOOK |
| 31 |
IMAGING SYSTEM |
MULTIPLE PRODUCT NAMES |
| 32 |
IMPACTOR |
MULTIPLE PRODUCT NAMES |
| 33 |
INTERBODY FIXATOR |
VERTE-SPAN SPINAL SYSTEM |
| 34 |
INTERVERTEBRAL DISC PROSTHESIS |
BRYAN TOTAL CERVICAL DISC,PRESTIGE CERVICAL DISC,MAVERICK TOTAL DISC REPLACEMENT |
| 35 |
METALLIC BONE FIXATION DEVICE |
TSRH SPINAL SYSTEM, CD HORIZON SPINAL SYSTEM |
| 36 |
MICROSURGICAL, INSTRUMENTS |
MICRO-ENDO SYSTEMS |
| 37 |
MUELLER |
MUELLER TYPE |
| 38 |
MULTI-AXIAL SCREW |
ALPHA POSTERIOR SPINAL SYSTEM |
| 39 |
MULTIPLE (BONE PLATES) |
MULTIPLE (BONE PLATES) |
| 40 |
MULTIPLE (CHISELS & OSTEOTOMES) |
MULTIPLE (CHISELS & OSTEOTOMES) |
| 41 |
MULTIPLE (DEPTH GAUGES) |
MULTIPLE (DEPTH GAUGES) |
| 42 |
MULTIPLE (DRIVER-EXTRACTORS) |
MULTIPLE (DRIVER-EXTRACTORS) |
| 43 |
MULTIPLE (ORTHOPEDIC CLAMPS) |
MULTIPLE (ORTHOPEDIC CLAMPS) |
| 44 |
MULTIPLE (ORTHOPEDIC CURETTES) |
MULTIPLE (ORTHOPEDIC CURETTES) |
| 45 |
MULTIPLE (ORTHOPEDIC OSTEOTOMES) |
MULTIPLE (ORTHOPEDIC OSTEOTOMES) |
| 46 |
MULTIPLE (ORTHOPEDIC REAMERS) |
MULTIPLE (ORTHOPEDIC REAMERS) |
| 47 |
MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS) |
MULTIPLE (PROXIMAL FEMORAL FIXATION DEVICES, NAILS, PLATES, SCREWS, PINS) |
| 48 |
MULTIPLE (SCISSORS) |
MULTIPLE (SCISSORS) |
| 49 |
MULTIPLE (SURGICAL MALLETS) |
MULTIPLE (SURGICAL MALLETS) |
| 50 |
MULTIPLE ELEVATORS, ORTHOPEDIC |
ELEVATOR, ORTHOPEDIC |
| 51 |
MULTIPLE FORCEPS |
MULTIPLE FORCEPS |
| 52 |
MULTIPLE PLIERS, SURGICAL |
PLIERS, SURGICAL |
| 53 |
MULTIPLE RETRACTORS |
RETRACTOR |
| 54 |
MULTPLE TAMPS |
MULTIPLE PRODUCT NAMES |
| 55 |
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
MULTIPLE PRODUCT NAMES |
| 56 |
ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE |
ORTHOSIS, SPINAL INTERVERTEBRAL FUSION, SOLID SPHERE |
| 57 |
ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
| 58 |
PLATE |
MULTIPLE PRODUCT NAMES |
| 59 |
PLATE AND SCREW COMPRESSION DEVICES |
MULTIPLE PRODUCT NAMES |
| 60 |
RULER |
BONE SCREW RULER |
| 61 |
SCREWDRIVER, ORTHOPEDIC |
MULTIPLE PRODUCT NAMES |
| 62 |
SCREWDRIVERS, WRENCHES, TAPS, GUIDE PINS, ETC. |
MULTIPLE PRODUCT NAMES |
| 63 |
SKIN CLOSURE CLIPS |
MICHEL CLIPS |
| 64 |
SOCKET |
MULTIPLE PRODUCT NAMES |
| 65 |
SPINAL FUSION DEVICE |
INTERFIX TM THREADED FUSION DEVICE |
| 66 |
SPINAL IMPLANT FIXATION DEVICE |
TSRH CROSSLINK SYSTEM |
| 67 |
SPINAL IMPLANT FIXATION DEVICES |
MULTIPLE PRODUCT NAMES |
| 68 |
SPINAL IMPLANT FIXATION DEVICES |
MULTIPLE PRODUCT NAMES |
| 69 |
STAPLE |
STAPLE |
| 70 |
STAPLE |
DYNAMIC COMPRESSION STAPLE SYSTEM |
| 71 |
SURGICAL CABLE |
ATLAS |
| 72 |
SURGICAL LAMP |
SURGICAL LAMP |
| 73 |
TEMPLATE |
TEMPLATE |
| 74 |
TENDON STRIPPER |
BUNNELL TENDON STRIPPER |
| 75 |
THOMPSON |
THOMPSON TYPE |
| 76 |
THOMPSON AND MOORE TYPE HIP PROSTHESES |
MULTIPLE PRODUCT NAMES |
| 77 |
UCSS, ATLAS |
UCSS, ATLAS |
| 78 |
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE CUP |
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE CUP |
| 79 |
VARIOUS (RONGEURS) |
MULTIPLE (RONGEURS) |
| 80 |
VARIOUS ABDOMINAL BINDERS |
MULTIPLE PRODUCT NAMES |
| 81 |
VARIOUS BENDERS |
MULTIPLE PRODUCT NAMES |
| 82 |
VARIOUS BOLTS AND NUTS |
MULTIPLE PRODUCT NAMES |
| 83 |
VARIOUS BONE SAWS |
MULTIPLE PRODUCT NAMES |
| 84 |
VARIOUS CARTILAGE KNIVES |
MULTIPLE PRODUCT NAMES |
| 85 |
VARIOUS DISSECTORS |
MULTIPLE PRODUCT NAMES |
| 86 |
VARIOUS ELECTROSURGICAL ACCESSORIES |
MULTIPLE ELECTROSURGICAL ACCESSORIES |
| 87 |
VARIOUS GOUGES |
MULTIPLE PRODUCT NAMES |
| 88 |
VARIOUS INPLANT FIXATION DEVICES, SPINAL - STERILE AND NON-STERILE |
MULTIPLE PRODUCT NAMES |
| 89 |
VARIOUS KNEE BRACES IMMOBILIZERS |
MULTIPLE PRODUCT NAMES |
| 90 |
VARIOUS RASPS |
MULTIPLE (ORTHOPEDIC RASPS) |
| 91 |
VARIOUS ROD BENDERS |
ROD BENDER |
| 92 |
VARIOUS RONGEURS |
RONGEUR |
| 93 |
VARIOUS SCOPES |
MULTIPLE PRODUCT NAMES |
| 94 |
VARIOUS SIZES OF SURGICAL PILLOWS |
INFLATABLE SURGICAL PILLOWS |
| 95 |
VARIOUS STYLES OF STEINMANN PINS AND KIRSHNER WIRES |
MULTIPLE PRODUCT NAMES |
| 96 |
VARIOUS STYLES OF THREADED STEINMANN PINS AND KIRSHNER WIRES |
MULTIPLE PRODUCT NAMES |
| 97 |
VARIOUS SURGICAL BURS |
MULTIPLE PRODUCT NAMES |
| 98 |
VARIOUS SURGICAL DRILLS |
MULTIPLE PRODUCT NAMES |
| 99 |
VARIOUS TENSION CRIMPER |
MULTIPLE PRODUCT NAMES |
| 100 |
VARIOUS TWIST, BIT DRILLS |
MULTIPLE TWIST, BIT DRILLS |
| 101 |
VARIOUS TYPES ARM SLINGS AND ARM/SHOULDER IMMOBILIZERS |
MULTIPLE PRODUCT NAMES |
| 102 |
VARIOUS TYPES OF ABDOMINAL BINDERS |
MULTIPLE PRODUCT NAMES |
| 103 |
VARIOUS TYPES OF ANKLE SPLINTS AND BRACES |
MULTIPLE PRODUCT NAMES |
| 104 |
VARIOUS TYPES OF CERVICAL COLLARS |
MULTIPLE PRODUCT NAMES |
| 105 |
VARIOUS TYPES OF CLAVICAL, ACROMIOCLAVICULAR, AND SHOULDER SPLINTS AND BRACES |
MULTIPLE PRODUCT NAMES |
| 106 |
VARIOUS TYPES OF DRILL GUIDES & GUIDE WIRES (PINS) |
DRILL GUIDES & GUIDE WIRES (PINS) |
| 107 |
VARIOUS TYPES OF HARD AND SOFT LIMB AND JOINT SPLINTS (SUPPORTS, BRACES) |
MULTIPLE PRODUCT NAMES |
| 108 |
VARIOUS TYPES OF HEAD HALTERS AND CERVICAL TRACTION DEVICES |
MULTIPLE PRODUCT NAMES |
| 109 |
VARIOUS TYPES OF INTRAMEDULLARY RODS |
MULTIPLE PRODUCT NAMES |
| 110 |
VARIOUS TYPES OF LUMBO-SACRAL SUPPORTS WITH AND WITHOUT PELVIC TRACTION |
MULTIPLE PRODUCT NAMES |
| 111 |
VARIOUS TYPES OF ORTHOPEDIC WIRE CUTTERS |
MULTIPLE PRODUCT NAMES |
| 112 |
VARIOUS TYPES OF ORTHOPEDIC WRENCHES |
MULTIPLE PRODUCT NAMES |
| 113 |
VARIOUS TYPES OF PADS AND HEEL AND ELBOW PROTECTORS |
MULTIPLE PRODUCT NAMES |
| 114 |
VARIOUS TYPES OF PELVIC TRACTION BELTS |
MULTIPLE PRODUCT NAMES |
| 115 |
VARIOUS TYPES OF PROSTHESIS DRIVERS |
MULTIPLE PRODUCT NAMES |
| 116 |
VARIOUS TYPES OF RIB BELTS |
MULTIPLE PRODUCT NAMES |
| 117 |
VARIOUS TYPES OF TRACTION BARS, WIRE TIGHTENERS |
MULTIPLE PRODUCT NAMES |
| 118 |
VARIOUS TYPES OF WEIGHTS, CORD, FRAMES, AND OTHER TRACTION ACC. |
MULTIPLE PRODUCT NAMES |
| 119 |
VARIOUS TYPES OF WRIST, HAND AND FINGER SPLINTS AND SOFT GOOD SUPPORTS |
MULTIPLE PRODUCT NAMES |
| All FDA-Registered products for this company are displayed above. |
Other Products Offered by WARSAW ORTHOPEDIC, INC.:
|
No products have been listed by this company.
Services Offered by the WARSAW ORTHOPEDIC, INC.:
|
|
No services have been listed by this company. |
Additional Contact Information for WARSAW ORTHOPEDIC, INC.:
|
| There is no additional contact information for this company. |
Companies Related to WARSAW ORTHOPEDIC, 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 SOFAMOR DANEK USA, INC.
|
4340 SWINNEA RD.
|
MEMPHIS |
TN |
38118 |
US |
| 22 |
MEDTRONIC SWISS MANUFACTURING FACILITY
|
ROUTE DU MOLLIAU 31
|
TOLOCHENAZ |
|
1131 |
SZ |
| 23 |
MEDTRONIC VASCULAR
|
35-37A CHERRY HILL DR
|
DANVERS |
MA |
01923 |
US |
| 24 |
MEDTRONIC VASCULAR
|
3576 UNOCAL PL.
|
SANTA ROSA |
CA |
95403 |
US |
| 25 |
MEDTRONIC XOMED INSTRUMENTATION S.A.S.
|
RUE LE PAVILLON
SAINT AUBIN LE MONIAL
|
BOURBON L'ARCHAMBAULT |
|
03160 |
FR |
| 26 |
MEDTRONIC XOMED, INC.
|
6743 SOUTHPOINT DR. NORTH
|
JACKSONVILLE |
FL |
32216 |
US |
| 27 |
MEDTRONIC XOMED, INC.
|
950 FLANDERS RD.
|
MYSTIC |
CT |
06355 |
US |
| 28 |
THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
|
1851 EAST DEERE AVE.
|
SANTA ANA |
CA |
92705 |
US |
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