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Sign in to claim this brandVILEX IN TENNESSEE, INC.
US
Last updated May 23, 2026
What VILEX IN TENNESSEE, INC. makes
The company manufactures reusable and single-use orthopaedic surgical instruments, including external fixation systems, bone wires, drill guides, implant templates, burs, screwdrivers, and countersinks. These tools are designed for orthopaedic procedures such as fracture fixation and bone alignment, with some products available in sterile packaging for surgical use.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from Tennessee, USA.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Vilex in Tennessee, Inc. manufacture?
Vilex in Tennessee, Inc. specializes in orthopaedic surgical instruments, including both reusable and single-use devices. Their portfolio covers external orthopaedic fixation systems (some sterile), orthopaedic bone wires, surgical drill guides, implant templates, orthopaedic burs, screwdrivers, and countersinks. These tools are primarily designed for procedures like fracture fixation and bone alignment.
Where is Vilex in Tennessee, Inc. based, and what does that mean for their regulatory oversight?
The company is headquartered in Tennessee, USA. Since they operate within the US, their devices are subject to FDA regulations, including classification under FDA’s device classification system (Class I or Class II). The US regulatory framework ensures their products meet safety and performance standards before entering the market.
Which regulatory registries or databases list Vilex in Tennessee, Inc.’s devices?
All of Vilex in Tennessee, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry assigns a standardized identifier to each device, improving traceability, tracking, and compliance with US regulatory requirements for medical products.
How are Vilex in Tennessee, Inc.’s devices classified under FDA regulations?
Vilex’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. Classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 152008371
Catalogue (892)
Page 18 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vilex Tool | ST-4843310 | FDA UDI | Class I | Active |
| eZ-Fix | 351-M6-04 | FDA UDI | Class II | Active |
| Vilex Power Accessory | DI201265R | FDA UDI | Class I | Active |
| eZ-Fix | K400-18PS | FDA UDI | Class II | Active |
| Vilex Tool | P460-35A | FDA UDI | Class I | Active |
| Orthex | R320-130S | FDA UDI | Class II | Active |
| eZ-Fix | 620-10-S | FDA UDI | Class II | Active |
| Vilex Power Accessory | K16150-06TN | FDA UDI | Class I | Active |
| Vilex Power Accessory | DS201265N | FDA UDI | Class I | Active |
| Orthex Half Pin | HPP50-150-35B | FDA UDI | Class II | Active |
| Orthex Tool | RB-130B | FDA UDI | Class II | Active |
| Vilex Jones Fracture Tool | JF-SDT20 | FDA UDI | Class I | Active |
| eZ-Fix | K400-15B | FDA UDI | Class II | Active |
| Orthex Tool | CB-060B | FDA UDI | Class II | Active |
| Orthex | C450-04-30 | FDA UDI | Class II | Active |
| eZ-Fix | 800-100 | FDA UDI | Class II | Active |
| eZ-Fix | 410-S7 | FDA UDI | Class II | Active |
| Vilex Power Accessory | DW411355R | FDA UDI | Class I | Active |
| Statix | 301-035-210 | FDA UDI | Class II | Active |
| Orthex Tool | CB-110B | FDA UDI | Class II | Active |
| Orthex | K400-15BN | FDA UDI | Class II | Active |
| Vilex Jones Fracture Tool | JF-DT20-NSR | FDA UDI | Class I | Active |
| Vilex Power Accessory | DW311055N | FDA UDI | Class I | Active |
| Orthex Half Pin | HPP50-150-45B | FDA UDI | Class II | Active |
| Vilex Tool | ZT702-08-12 | FDA UDI | Class I | Active |
| eZ-Fix | 310-320-140 | FDA UDI | Class II | Active |
| Orthex | 350-M4-04 | FDA UDI | Class II | Active |
| Orthex | C351-M4-04 | FDA UDI | Class II | Active |
| Vilex Power Accessory | BS9525FN | FDA UDI | Class I | Active |
| Orthex Half Pin | HPP50-150-15B | FDA UDI | Class II | Active |
| Vilex Tool | P670-14-16 | FDA UDI | Class I | Active |
| Orthex | C670-40 | FDA UDI | Class II | Active |
| Orthex | R320-155 | FDA UDI | Class II | Active |
| Vilex Guidewire | K250-20S | FDA UDI | Class I | Active |
| Orthex Drill Cannulated | Z402-200-45 | FDA UDI | Class I | Active |
| Ultima HA Coated Half Pins and Wire | K163487 | FDA 510(k) | Class II | Active |
| Small Bone Nail Implant | K151456 | FDA 510(k) | Class II | Active |
| X-Fix Line Additions | K151881 | FDA 510(k) | Class II | Active |
| EzFuze Implant System | K150211 | FDA 510(k) | Class II | Active |
| Bone Screw Line Addition | K191289 | FDA 510(k) | Class II | Active |
| Trident Fusion Implant | K141937 | FDA 510(k) | Class II | Active |
| Cannulated Hemi Implant | K190543 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Vilex in Tennessee, Inc. has three recall records, all initiated on 2015-04-22, with each listed as terminated. The recalls were prompted by reports of higher-than-expected incidence of breakage in the affected products.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 22, 2015 | Z-1721-2015 | — | terminated | Incidence of breakage is higher than expected. |
| Apr 22, 2015 | Z-1722-2015 | — | terminated | Incidence of breakage is higher than expected. |
| Apr 22, 2015 | Z-1723-2015 | — | terminated | Incidence of breakage is higher than expected. |