3.4mm x 3.0mm x 8mm Two-Step Hammer Toe Implant

GUDID 00812926021942

TRILLIANT SURGICAL, LTD.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00812926021942
• NIH Device Record Key: 6a1c6287-5e87-43f4-853c-a06df4a07fe0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.4mm x 3.0mm x 8mm Two-Step Hammer Toe Implant
• Version Model Number: 204-30-008
• Company DUNS: 828829072
• Company Name: TRILLIANT SURGICAL, LTD.
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926021942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122959

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

Moist Heat or Steam Sterilization

[00812926021942]

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: 2017-03-13

Devices Manufactured by TRILLIANT SURGICAL, LTD.

• 00810028391512 - Arsenal Petite MPJ Plate, L, 0°: 2021-09-13
• 00810028391529 - Arsenal Petite MPJ Plate, R, 0°: 2021-09-13
• 00810028391536 - Arsenal Petite MPJ Plate, L, 5°: 2021-09-13
• 00810028391543 - Arsenal Petite MPJ Plate, R, 5°: 2021-09-13
• 00810028391550 - Arsenal Short 5th Met Hook Plate, L: 2021-09-13
• 00810028391567 - Arsenal Short 5th Met Hook Plate, R: 2021-09-13
• 00810028391574 - Arsenal U-Plate, Small, L: 2021-09-13
• 00810028391581 - Arsenal U-Plate, Small, R: 2021-09-13