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FDA-Registered Company Profile for SYNTHES (USA)
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FDA-Supplied Establishment Information: |
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Establishment Registration Number: |
1719045 |
Company Name: |
SYNTHES (USA) |
Also Known As: |
NORIAN
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Address: |
1051-1101 SYNTHES AVE. |
Address 2: |
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City: |
MONUMENT |
State |
CO |
Zip / Postal Code: |
80132 |
County: |
EL PASO |
Country: |
US |
Establishment Operation Code(s): |
AA - Initial Distributor
MM - Manufacturer
MR - Remanufacturer
RR - Repackager/Relabeller
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Establishment Status Code: |
A -
Active
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Year of Most Recent Initial or Annual Registration: |
2007 |
FDA-Supplied Owner/Operator Information: |
Owner/Operator Number: |
2520274 |
Company Name: |
SYNTHES (USA)
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Address: |
1302 WRIGHTS LANE EAST |
Address 2: |
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City: |
WEST CHESTER |
State: |
PA |
Zip / Postal Code: |
19380 |
Country: |
US |
Owner/Operator Phone: |
610-719-5000
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FDA-Supplied Official Correspondent Information: |
Official Correspondent Name: |
ANGELA SILVESTRI |
Company Name: |
SYNTHES (USA) |
Address: |
1230 WILSON DR. |
Address 2: |
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City: |
WEST CHESTER |
State: |
PA |
Zip / Postal Code: |
19380 |
Country: |
US |
Official Corespondent Phone Number: |
484-356-9728
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Other Establishment Information: |
Establishment Phone: |
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Fax: |
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General Email: |
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Web Site: |
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Company Brochure: |
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Keywords: |
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Company Description: |
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Services Offered: |
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About Us: |
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Differentiation: |
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FDA-Registered Products Offered by SYNTHES (USA)
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Common Device Name |
Proprietary Device Name |
1 |
ACCESSORIES ARTHROSCOPIC |
MULTIPLE PRODUCT NAMES |
2 |
BONE CEMENT, STERILE |
NORIAN CRS CRANIOFACIAL REPAIR SYSTEM |
3 |
BONE PLATE AND SCREWS |
ORTHODONTIC BONE ANCHOR SYSTEM |
4 |
COMPARTMENTAL PRESSURE MONITORING SYSTEM |
MULTIPLE PRODUCT NAMES |
5 |
CRANIOPLASTY PLATE FASTENER |
MULTIPLE PRODUCT NAMES |
6 |
INTRAORAL LIGATURE AND WIRE LOCK |
LOCK, WIRE, AND LIGATURE, INTRAORAL |
7 |
LAMP, OPERATING ROOM |
MULTIPLE PRODUCT NAMES |
8 |
LOCKING RECONSTRUCTION PLATE WITH CONDYLAR HEAD |
MANIDBULAR CONDYLE PROSTHESIS |
9 |
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
MULTIPLE PRODUCT NAMES |
10 |
MULTIPLE |
MULTIPLE PRODUCT NAMES |
11 |
PREFORMED ALTERABLE CRANIOPLASTY PLATE |
MULTIPLE PRODUCT NAMES |
12 |
PREFORMED NONALTERABLE CRANIOPLASTY PLATE |
MULTIPLE PRODUCT NAMES |
13 |
PRESSURE REGULATORS |
REGULATORS |
14 |
SURGICAL INSTR. MOTORS AND ACCESSORIES/ATTACHMENTS |
MULTIPLE PRODUCT NAMES |
15 |
SURGICAL INSTR. MOTORS AND ACCESSORIES/ATTACHMENTS |
MULTIPLE PRODUCT NAMES |
16 |
SUTURE GRASPER |
SUTURE GRASPER |
17 |
TORQUE LIMITER |
TORQUE LIMITING ATTACHMENT |
18 |
VARIOUS ORTHOSIS, SPINAL PEDICLE FIXATION PRODUCTS |
MULTIPLE PRODUCT NAMES |
19 |
VARIOUS SPATULA, ORTHOPEDIC PRODUCTS |
MULTIPLE PRODUCT NAMES |
20 |
VARIOUS DISPENSER, CEMENT PRODUCTS |
MULTIPLE PRODUCT NAMES |
21 |
VARIOUS NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE PRODUCTS |
MULTIPLE PRODUCT NAMES |
22 |
VARIOUS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT PRODUCTS |
MULTIPLE PRODUCT NAMES |
23 |
VARIOUS AWL PRODUCTS |
AWL |
24 |
VARIOUS APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT PRODUCTS |
MULTIPLE PRODUCT NAMES |
25 |
VARIOUS RASP PRODUCTS |
MULTIPLE PRODUCT NAMES |
26 |
VARIOUS REAMER PRODUCTS |
MULTIPLE PRODUCT NAMES |
27 |
VARIOUS HAMMER, SURGICAL PRODUCTS |
MULTIPLE PRODUCT NAMES |
28 |
VARIOUS TWISTER, WIRE PRODUCTS |
MULTIPLE PRODUCT NAMES |
29 |
VARIOUS EXTRACTOR PRODUCTS |
MULTIPLE PRODUCT NAMES |
30 |
VARIOUS IMPLANT, FIXATION DEVICE, CONDYLAR PLATE PRODUCTS |
MULTIPLE PRODUCT NAMES |
31 |
VARIOUS OSTEOTOME PRODUCTS |
MULTIPLE PRODUCT NAMES |
32 |
VARIOUS INSTRUMENT, COMPRESSION PRODUCTS |
MULTIPLE PRODUCT NAMES |
33 |
VARIOUS FORCEPS, GENERAL & PLASTIC SURGERY PRODUCTS |
MULTIPLE PRODUCT NAMES |
34 |
VARIOUS COUNTERSINK PRODUCTS |
MULTIPLE PRODUCT NAMES |
35 |
VARIOUS MALLET PRODUCTS |
MULTIPLE PRODUCT NAMES |
36 |
VARIOUS MIXER, CEMENT, FOR CLINICAL USE PRODUCTS |
MULTIPLE PRODUCT NAMES |
37 |
VARIOUS AND SIZES OF IMPACTORS |
MULTIPLE PRODUCT NAMES |
38 |
VARIOUS AND SIZES OF ORTHOPAEDIC,CUTTING INSTRUMENTS |
MULTIPLE PRODUCT NAMES |
39 |
VARIOUS TYPES AND SIZES OF BENDING AND CONTOURING INSTRUMENT |
MULTIPLE PRODUCT NAMES |
40 |
VARIOUS TYPES AND SIZES OF BONE FIXATION NAILS.,STERILE AND NON-STERILE |
MULTIPLE PRODUCT NAMES |
41 |
VARIOUS TYPES AND SIZES OF BONE FIXATION PLATES |
MULTIPLE PRODUCT NAMES |
42 |
VARIOUS TYPES AND SIZES OF BONE FIXATION SCREWS |
SCREW |
43 |
VARIOUS TYPES AND SIZES OF BONE PLATES |
MULTIPLE PRODUCT NAMES |
44 |
VARIOUS TYPES AND SIZES OF BONE SCREW STARTERS |
MULTIPLE PRODUCT NAMES |
45 |
VARIOUS TYPES AND SIZES OF BONE TAPS |
MULTIPLE PRODUCT NAMES |
46 |
VARIOUS TYPES AND SIZES OF BURR HOLE COVERS |
MULTIPLE PRODUCT NAMES |
47 |
VARIOUS TYPES AND SIZES OF CURETTES |
CURETTE |
48 |
VARIOUS TYPES AND SIZES OF ELEVATORS |
MULTPLE |
49 |
VARIOUS TYPES AND SIZES OF EXTERNAL FIXATION CLAMPS, RODS, BARS, AND TUBES, ETC. |
MULTIPLE PRODUCT NAMES |
50 |
VARIOUS TYPES AND SIZES OF FIXATION CERCLAGES |
MULTIPLE PRODUCT NAMES |
51 |
VARIOUS TYPES AND SIZES OF FORCEPS |
MULTIPLE PRODUCT NAMES |
52 |
VARIOUS TYPES AND SIZES OF GUIDES AND SLEEVES |
MULTIPLE PRODUCT NAMES |
53 |
VARIOUS TYPES AND SIZES OF INTRAMEDULLARY FIXATION RODS, STERILE AND NON-STERILE |
MULTIPLE PRODUCT NAMES |
54 |
VARIOUS TYPES AND SIZES OF INTRAOSSEOUS FIXATION SCREWS |
SCREW |
55 |
VARIOUS TYPES AND SIZES OF INTRAOSSEOUS WIRES |
MULTIPLE PRODUCT NAMES |
56 |
VARIOUS TYPES AND SIZES OF MEASURING DEVICES |
MULTIPLE PRODUCT NAMES |
57 |
VARIOUS TYPES AND SIZES OF NON-POWERED,APPARATUS,TRACTIONS |
MULTIPLE PRODUCT NAMES |
58 |
VARIOUS TYPES AND SIZES OF NONABSORBABLE STEEL SUTURES |
MULTIPLE PRODUCT NAMES |
59 |
VARIOUS TYPES AND SIZES OF ORTHOPAEDIC INSTRUMENTS |
MULTIPLE PRODUCT NAMES |
60 |
VARIOUS TYPES AND SIZES OF PNEUMATIC ACCESSORIES AND ATTACHMENTS |
MULTIPLE PRODUCT NAMES |
61 |
VARIOUS TYPES AND SIZES OF POSITIONING PLATES |
MULTIPLE PRODUCT NAMES |
62 |
VARIOUS TYPES AND SIZES OF PROXIMAL FEMUR,FIXATION DEVICE,APPLIANCES,STERILE AND |
MULTIPLE PRODUCT NAMES |
63 |
VARIOUS TYPES AND SIZES OF RETRACTORS |
MULTIPLE PRODUCT NAMES |
64 |
VARIOUS TYPES AND SIZES OF ROGEURS |
RONGEUR |
65 |
VARIOUS TYPES AND SIZES OF SCREWDRIVERS |
MULTIPLE PRODUCT NAMES |
66 |
VARIOUS TYPES AND SIZES OF SMOOTH FIXATION PINS |
MULTIPLE PRODUCT NAMES |
67 |
VARIOUS TYPES AND SIZES OF SPINAL INTERLAMINAL FIXATION APPLIANCES |
MULTIPLE PRODUCT NAMES |
68 |
VARIOUS TYPES AND SIZES OF SPINAL INTERVERTEBRAL,FIXATION APPLIANCES |
MULTIPLE PRODUCT NAMES |
69 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE INVASIVE TRACTION COMPONENTS |
MULTIPLE PRODUCT NAMES |
70 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE WASHERS,NUTS AND BOLTS |
MULTIPLE PRODUCT NAMES |
71 |
VARIOUS TYPES AND SIZES OF SURGICAL BONE CHISELS |
CHISEL |
72 |
VARIOUS TYPES AND SIZES OF SURGICAL INSTRUMENT RACKS |
MULTIPLE PRODUCT NAMES |
73 |
VARIOUS TYPES AND SIZES OF SURGICAL MESH |
MULTIPLE PRODUCT NAMES |
74 |
VARIOUS TYPES AND SIZES OF SURGICAL PLIERS |
MULTIPLE PRODUCT NAMES |
75 |
VARIOUS TYPES AND SIZES OF SURGICAL WIRE |
MULTIPLE PRODUCT NAMES |
76 |
VARIOUS TYPES AND SIZES OF SURGICAL,GENERAL PLASTIC SURGERY HOOKS |
HOOK |
77 |
VARIOUS TYPES AND SIZES OF THREADED FIXATION PINS |
MULTIPLE PRODUCT NAMES |
78 |
VARIOUS TYPES AND SIZES OF WIRE TIGHTNERS/TAMPS |
MULTIPLE PRODUCT NAMES |
79 |
VARIOUS TYPES AND SIZES OF WRENCHES |
MULTIPLE PRODUCT NAMES |
80 |
VARIOUS TYPES AND SIZES SURGICAL INSTRUMENT CHISELS |
CHISEL |
81 |
VARIOUS TYPES OF SIZES OF FIBEROPTIC RETRACTORS |
MULTIPLE PRODUCT NAMES |
82 |
VARIOUS TYPES SIZES OF DRILL BITS AND VARIOUS DRILLS AND ACCESSORIES |
MULTIPLE PRODUCT NAMES |
83 |
VARIOUS TYPES SIZES OF NONPOWERED GONIOMETERS |
GONIOMETER |
84 |
VARIOUS TYPES&SIZES OF MANDIBULAR EXT.FIX. & AND/OR DIST. |
MULTIPLE PRODUCT NAMES |
85 |
VERTICAL EXPANDABLE PROSTHETIC RIB, VEPTR |
VERTICAL EXPANDABLE PROSTHETIC RIB, VEPTR |
All FDA-Registered products for this company are displayed above. |