FuzeFix Twist Off TN-TR-0006

GUDID 00819034023257

Modular Screw Tray

FUSION ORTHOPEDICS, LLC

Instrument tray, reusable

• Primary Device ID: 00819034023257
• NIH Device Record Key: 2d5936d7-fae6-49f7-b0b3-4b8adeed3758
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Twist Off
• Version Model Number: TN-TR-0006
• Catalog Number: TN-TR-0006
• Company DUNS: 080307067
• Company Name: FUSION ORTHOPEDICS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: true
• 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	00819034023257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170038

FDA Product Code

• OJH: Orthopedic Tray

Sterilization

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

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

[00819034023257]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-27
• Device Publish Date: 2025-05-19

On-Brand Devices [FuzeFix Twist Off]

• 00819034023196: TN-FX-8030 Depth Guage
• 00819034021864: Twist Off Driver Stem Driver 2.0mm
• 00819034021857: Twist Off Driver Stem Driver 2.5mm
• 00819034021840: Twist Off Driver Breakaway Driver 2.0mm
• 00819034021833: Twist Off Driver Breakaway Driver 2.5mm
• 00840124518995: Depth Gauge Twist Off
• 00819034023257: Modular Screw Tray