Vilex Fibula Tool ZF-CANN-S

GUDID 00841731121967

Sleeve, Targeting, Fibula 3.5mm Nail

VILEX IN TENNESSEE, INC.

Surgical drill guide, reusable

• Primary Device ID: 00841731121967
• NIH Device Record Key: fbd26d0d-b5b4-446c-b38b-2b20a0d79e2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Fibula Tool
• Version Model Number: ZF-CANN-S
• Catalog Number: ZF-CANN-S
• 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: false
• 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	00841731121967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151456

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00841731121967]

Moist Heat or Steam Sterilization

[00841731121967]

Moist Heat or Steam Sterilization

[00841731121967]

Moist Heat or Steam Sterilization

[00841731121967]

Moist Heat or Steam Sterilization

[00841731121967]

Moist Heat or Steam Sterilization

[00841731121967]

Moist Heat or Steam Sterilization

[00841731121967]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-08-14

On-Brand Devices [Vilex Fibula Tool]

• 00841731122032: Driver, Fibula T10 Long
• 00841731122025: Reamer, Fibula Proximal 3.4mm Cann QC
• 00841731122018: Reamer, Fibula Distal 6.2mm Cann QC
• 00841731121981: Drill Sleeve, Fibula Nail, 2.5mm
• 00841731121974: Drill Sleeve, Fibula Nail, 2.0mm
• 00841731121967: Sleeve, Targeting, Fibula 3.5mm Nail
• 00841731121950: Sleeve, Targeting, Fibula 2.7mm Nail
• 00841731123299: Targeting, Fibula Nail, Long Screw
• 00841731123282: Targeting, Fibula Nail, Short Screw