Vilex Plate

GUDID 00841731115430

Plate, AFP 60mm Right Ti Lkng

VILEX IN TENNESSEE, INC.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731115430
• NIH Device Record Key: 54a095f5-a937-423c-af32-d833a9fd3a5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilex Plate
• Version Model Number: AFP60R
• 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	00841731115430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041287

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00841731115430]

Moist Heat or Steam Sterilization

[00841731115430]

Moist Heat or Steam Sterilization

[00841731115430]

Moist Heat or Steam Sterilization

[00841731115430]

Moist Heat or Steam Sterilization

[00841731115430]

Moist Heat or Steam Sterilization

[00841731115430]

Moist Heat or Steam Sterilization

[00841731115430]

Moist Heat or Steam Sterilization

[00841731115430]

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: 2017-02-20

On-Brand Devices [Vilex Plate]

• 00841731121622: Plate, Straight 65mm R Lkng_Ti Magenta
• 00841731121615: Plate, Straight 65mm L Lkng_Ti Magenta
• 00841731121608: Plate, Straight 60mm R Lkng_Ti Magenta
• 00841731121592: Plate, Straight 60mm L Lkng_Ti Magenta
• 00841731121585: Plate, Straight 55mm R Lkng_Ti Magenta
• 00841731121578: Plate, Straight 55mm L Lkng_Ti Magenta
• 00841731121554: Plate, Rectangle Lkng_Ti Magenta
• 00841731121547: Plate, Star 4 holes Lkng-Ti Magenta
• 00841731121295: Plate, Five hole str Non-Lkng_Ti Green
• 00841731121264: Plate, 32mm 5 hole Non-Lkng_Ti Green
• 00841731121257: Plate, Str L Non-Lkng_Ti Green
• 00841731121240: Plate, Angled L Non-Lkng_Ti Green
• 00841731121233: Plate, Str Non-Lkng_Ti Green
• 00841731121226: Plate, Str L 34" 5 hole Non-Lkng_Ti Green
• 00841731121158: Plate, T-Shape 4 holes Non-Lkng_Ti Green
• 00841731121141: Plate, Straight R 18mm 4 hole Non-Lkng_Ti Green
• 00841731121134: Plate, Angled R Non-Lkng_Ti Green
• 00841731121127: Plate, Straight L Non-Lkng_Ti Green
• 00841731120991: Plate, Locking 19mm
• 00841731120984: Plate, Lapidus, 40mm Step 4_Ti Magenta
• 00841731120977: Plate, Lapidus, 40mm Step 3_Ti Magenta
• 00841731120960: Plate, Lapidus, 40mm Step 2_Ti Magenta
• 00841731120953: Plate, Lapidus, 30mm Step 4_Ti Magenta
• 00841731120946: Plate, Lapidus, 30mm Step 3_Ti Magenta
• 00841731120939: Plate, Lapidus, 30mm Step 2_Ti Magenta
• 00841731120243: Plate, Double locking MPJ 65mm
• 00841731120236: Plate, Double locking MPJ 55mm
• 00841731120205: Plate, Locking Flex 65mm
• 00841731120199: Plate, Locking Flex 65mm
• 00841731120182: Plate, Locking Flex 60mm
• 00841731120175: Plate, Locking Flex 60mm
• 00841731120168: Plate, Locking Flex 55mm
• 00841731120151: Plate, Locking Flex 55
• 00841731120144: Plate, Locking Flex 50mm
• 00841731120137: Plate, Locking Flex 50
• 00841731120120: Plate, Calcaneal locking 65mm
• 00841731120113: Plate, Calcaneal locking 65mm
• 00841731120106: Plate, Calcaneal locking 60mm
• 00841731120090: Plate, Calcaneal locking 60mm
• 00841731120083: Plate, Calcaneal locking 55mm
• 00841731120076: Plate, Calcaneal locking 55mm
• 00841731120069: Plate, Calcaneal locking 50mm
• 00841731120052: Plate, Calcaneal locking 50mm
• 00841731119742: Plate, 23x45 Non-Lkng_Ti Green
• 00841731115430: Plate, AFP 60mm Right Ti Lkng
• 00841731115157: Plate, AFP 60mm Left Ti Lkng
• 00841731115119: Plate, AFP 52mm Rght,Ti Lkng
• 00841731114785: Plate, AFP 52mm Left Ti Lkng
• 00841731108418: Plate, MPJ 16x54 Right Lkng_Ti Magenta
• 00841731108401: Plate, MPJ 16x54 Left Lkng_Ti Magenta