3.5mm x 55mm Arsenal Locking Screw

GUDID 00810028392069

Trilliant Surgical, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00810028392069
• NIH Device Record Key: 9f38f2fb-cc4c-4d7f-89ec-92823bc8ef0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm x 55mm Arsenal Locking Screw
• Version Model Number: 308-35-055
• Company DUNS: 828829072
• Company Name: Trilliant Surgical, LLC
• 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	00810028392069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212378

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

[00810028392069]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-10
• Device Publish Date: 2022-05-02

Devices Manufactured by Trilliant Surgical, LLC

• 00190446898757 - Stabilization: 2025-07-09 2.0mm ARSENAL DRILL
• 00190446898764 - Stabilization: 2025-07-09 2.7mm ARSENAL DRILL
• 00190446898771 - Stabilization: 2025-07-09 3.5mm ARSENAL DRILL
• 00190446898795 - Stabilization: 2025-07-09 Arsenal Bending Pliers
• 00190446898818 - Stabilization: 2025-07-09 ARSENAL 2.7mm Drill Guide
• 00190446898825 - Stabilization: 2025-07-09 ARSENAL 3.5mm Drill Guide
• 00190446898832 - Stabilization: 2025-07-09 ARSENAL 2.7mm / 3.5mm Compression Drill Guide
• 00190446910091 - Stabilization: 2025-07-09 FA - Arsenal Foot Plating Tray Lid