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VILEX 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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LinkedIn
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Facebook
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Email
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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 8 of 18
DeviceModel / ReferenceRegistriesClassStatus
Orthex K250-18BN
FDA UDI
Class IIActive
Orthex R320-205
FDA UDI
Class IIActive
eZ-Fix M750-FMC
FDA UDI
Class IIActive
Orthex C350T-M4-04
FDA UDI
Class IIActive
Orthex C605-F4
FDA UDI
Class IIActive
eZ-Fix 605-10
FDA UDI
Class IIActive
Vilex Guidewire K300-20
FDA UDI
Class IActive
eZ-Fix 330-090L
FDA UDI
Class IIActive
Vilex Tool ZT622-12
FDA UDI
Class IActive
Vilex Tool Z631-20
FDA UDI
Class IActive
Orthex C100-110
FDA UDI
Class IIActive
Vilex Guidewire K230-25T
FDA UDI
Class IActive
Vilex Guidewire K150-11PT
FDA UDI
Class IActive
Vilex Tool X600-11-78
FDA UDI
Class IActive
eZ-Fix 300-100-140
FDA UDI
Class IIActive
Vilex Tool Z636-210
FDA UDI
Class IActive
eZ-Fix 300-100-160 T6
FDA UDI
Class IIActive
Vilex Power Accessory K16150-12N
FDA UDI
Class IActive
eZ-Fix 420-M2
FDA UDI
Class IIActive
Orthex Half Pin HPP40-150-20B
FDA UDI
Class IIActive
eZ-Fix M750-RB
FDA UDI
Class IIActive
Orthex Half Pin HPP50-150-10B
FDA UDI
Class IIActive
Orthex CS75-105
FDA UDI
Class IIActive
Orthex 350T-M6-04
FDA UDI
Class IIActive
eZ-Fix 635-11
FDA UDI
Class IIActive
Vilex Guidewire K100-09D
FDA UDI
Class IActive
Vilex Tool X630-16-13
FDA UDI
Class IActive
Orthex Drill Cannulated Z402P-200-35
FDA UDI
Class IIActive
Orthex C450-04-120
FDA UDI
Class IIActive
Vilex Power Accessory K11150-12N
FDA UDI
Class IActive
Orthex Half Pin HP30-200-10B
FDA UDI
Class IIActive
eZ-Fix 350-F
FDA UDI
Class IIActive
Orthex C-Ball
FDA UDI
Class IIActive
Vilex Tool XTAL-06
FDA UDI
Class IActive
Vilex Tool ZBCF-50-20
FDA UDI
Class IActive
eZ-Fix 330-120R
FDA UDI
Class IIActive
eZ-Fix 610-06N
FDA UDI
Class IIActive
eZ-Fix K400-15BP
FDA UDI
Class IIActive
Orthex Half Pin HPP30-150-10B
FDA UDI
Class IIActive
Vilex Guidewire K100-12S
FDA UDI
Class IActive
Orthex CS-19-1
FDA UDI
Class IIActive
Orthex Tool P460-48-155
FDA UDI
Class IActive
Vilex Power Accessory K16225-12N
FDA UDI
Class IActive
Vilex Guidewire K625-25BE
FDA UDI
Class IActive
eZ-Fix 450-06-41
FDA UDI
Class IIActive
Orthex AS-12-1
FDA UDI
Class IIActive
Vilex Guidewire K150-09D
FDA UDI
Class IActive
eZ-Fix 530-075-20
FDA UDI
Class IIActive
Vilex Tool Z622-11
FDA UDI
Class IActive
Orthex Half Pin HP60-200-20B
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

DateRecall No.ClassStatusReason
Apr 22, 2015Z-1721-2015—terminated

Incidence of breakage is higher than expected.

Apr 22, 2015Z-1722-2015—terminated

Incidence of breakage is higher than expected.

Apr 22, 2015Z-1723-2015—terminated

Incidence of breakage is higher than expected.