FDA Registration
Active
🇺🇸 United States
TRIGON AMERICA LLC
Reg #: 3003596442
·
FEI: 3003596442
·
Expires 2026
Products
18
Proprietary Names
18
Establishment Types
1
Classifications
18
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Registration Details
- Registration Name
- TRIGON AMERICA LLC
- Registration Number
- 3003596442
- FEI Number
- 3003596442
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4000 Sussex Ave
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
Owner / Operator
- Firm Name
- Trigon America
- Operator Number
- 9047892
- Address
- 4000 Sussex Ave, --
- City
- Aurora
- State
- IL
- Postal Code
- 60504
- Country
- US
- Correspondent
- Tom Fenoglio
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Broach | HTQ | Class 1 | Orthopedic | No | 2026-01-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-12-07 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-12-07 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2012-12-07 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2012-12-07 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2012-12-10 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2026-01-19 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2012-12-10 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2026-01-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-12-12 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-03-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-12-10 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2012-12-10 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2026-01-19 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-12-10 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-01-19 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2026-01-19 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2012-12-10 |
Proprietary Names
BROACH
GUIDE, SURGICAL, INSTRUMENT
BIT, DRILL
EXTRACTOR
DRIVER, PROSTHESIS
REAMER
DEPTH GAUGE
AWL
DISPOSABLE SURGICAL INSTRUMENT
Orthopedic Manual Surgical Instrument
PERSONA REVISION KNEE SYSTEM GENERAL INSTRUMENTATION
TEMPLATE
RASP
IMPACTOR
RETRACTOR
ROSA Straight Cup Inserter Shaft
ROSA Offset Cup Inserter Shaft
DRIVER, SURGICAL, PIN
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)