FuzeFix Twist Off TN-FX-8030

GUDID 00840124518995

Depth Gauge Twist Off

FUSION ORTHOPEDICS, LLC

Surgical depth gauge, reusable

• Primary Device ID: 00840124518995
• NIH Device Record Key: b628dfef-ca1b-42cb-99ad-3789fcaf4b65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Twist Off
• Version Model Number: TN-FX-8030
• Catalog Number: TN-FX-8030
• 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	00840124518995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170038

FDA Product Code

• HTJ: Gauge, Depth

Sterilization

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

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

[00840124518995]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-22
• Device Publish Date: 2025-05-14

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