Talus of Vilex (TOV)

GUDID 00841731106612

TOV Implant 18mm_Ti Bronze

VILEX IN TENNESSEE, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731106612
• NIH Device Record Key: 98530c35-ab6c-48c4-ba82-2f8679b59f41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Talus of Vilex (TOV)
• Version Model Number: TOV8-18
• Company DUNS: 152008371
• Company Name: VILEX IN TENNESSEE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731106612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041289

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841731106612]

Moist Heat or Steam Sterilization

[00841731106612]

Moist Heat or Steam Sterilization

[00841731106612]

Moist Heat or Steam Sterilization

[00841731106612]

Moist Heat or Steam Sterilization

[00841731106612]

Moist Heat or Steam Sterilization

[00841731106612]

Moist Heat or Steam Sterilization

[00841731106612]

Moist Heat or Steam Sterilization

[00841731106612]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-03

On-Brand Devices [Talus of Vilex (TOV)]

• 00841731112835: TOVII Implant 07mm cylindrical_Ti
• 00841731106643: TOVII Implant 10mm cylindrical_Ti
• 00841731106636: TOVII Implant 09mm cylindrical_Ti
• 00841731106629: TOVII Implant 08mm cylindrical_Ti
• 00841731106612: TOV Implant 18mm_Ti Bronze
• 00841731106605: TOV Implant 16mm_Ti Magenta
• 00841731106599: TOV Implant 14mm_Ti D.Blue
• 00841731106582: TOV Implant 12mm_Ti Bronze
• 00841731106575: TOV Implant 11mm_Ti Green
• 00841731106568: TOV Implant 10mm_Ti Magenta
• 00841731106551: TOV Implant 09mm_Ti Gold
• 00841731106544: TOV Implant 08mm_Ti D.Blue
• 00841731106537: TOV Implant 07mm_Ti L.Blue