FDA Registration
Active
🇺🇸 United States
Vilex LLC
Reg #: 1051526
·
FEI: 1051526
·
Expires 2026
Products
22
Proprietary Names
46
Establishment Types
2
Classifications
22
Registration Details
- Registration Name
- Vilex LLC
- Registration Number
- 1051526
- FEI Number
- 1051526
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 111 MOFFITT ST
- City
- MCMINNVILLE
- State
- TN
- ZIP
- 37110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230462
Owner / Operator
- Firm Name
- Vilex LLC
- Operator Number
- 1051526
- Address
- 111 MOFFITT STREET, --
- City
- Mc Minnville
- State
- TN
- Postal Code
- 37110
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ankle Arthroplasty Implantation System | OYK | Class 2 | Orthopedic | No | 2024-02-22 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2024-02-22 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2016-11-02 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-07-31 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2019-07-31 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2008-11-03 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2008-11-03 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2016-09-21 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-07-19 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 1992-06-23 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2008-11-03 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 1997-09-23 |
| Kidney Perfusion Kit | PIN | Class 2 | Gastroenterology, Urology | No | 2026-04-21 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-07-12 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1992-06-23 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2012-10-17 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2023-07-19 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 1991-04-26 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2023-07-19 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2023-07-19 |
| Probe | HXB | Class 1 | Orthopedic | No | 2023-07-19 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2023-07-19 |
Proprietary Names
OPTIX H2 Patient Specific Instrument System
Small Bone Implant System
Hintermann Series H2 Total Ankle System
Jones Fracture
TITANEX ARTEMIS Screw System
TITANEX MICROBEAM Screw System
VILEX BONE PLATE SYSTEM
AVID Plate System
VILEX EZ-FIX
Orthex
TITANEX Screw Systems
Blade Handle, Vilex EPF/MEND
LAG SCREW - TITANIUM/STAINLESS
VILEX FUZE SYSTEM
Electric Power Unit and accessories for small bone surgery
CANNULATED HEMI TOE IMPLANT
CHUCK
ECO DRIVER W
REDEMPTION DUO Hindfoot Nail System
DYNEX External Fixation Systems
DUAL THREAD BONE SCREW
Titanex II
ALPHALOK Plating System
MET-HEAD IMPLANT
HammerFuze
Talex
TALUS OF VILEX (TOV)
TACTIX Vector Syndesmosis System
Cannulated Driver
Titanex, Lag Screw - Titanium/Stainless
REDEMPTION Beaming System
CANNULATED HEMI TOE IMPLANT - HA COATING
Nitinex
Vilex Memory Staple
Dynex Ring Fixation System Diametrix Ring Fixation System
LAG SCREW - STAINLESS
Blade, Vilex EPF/MEND
NITINEX Memory Compression Staple
Burrs for power accessories
Instrument, Vilex EPF/MEND
Spreader, Vilex EPF/MEND
Orthex Half Pin
Ultima Half Pin
Probe, Vilex EPF/MEND
Elevator, Vilex EPF/MEND
Dynex Micro
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device