FuzeFix Max FT TN-FT-9135

GUDID 00840124506664

Tissue Protector 3.5mm

FUSION ORTHOPEDICS, LLC

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00840124506664
• NIH Device Record Key: 367471c7-bb41-4f75-ba27-d31df4cedda4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Max FT
• Version Model Number: TN-FT-9135
• Catalog Number: TN-FT-9135
• 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: true
• 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	00840124506664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170038

FDA Product Code

• QAC: Screw Sleeve Bone Fixation Device

Sterilization

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

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

[00840124506664]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [FuzeFix Max FT]

• 00819034028344: K-Wire Threaded 1.4mm
• 00819034028337: K-Wire Standard 1.4mm
• 00819034023189: Depth Gauge FT
• 00819034023158: Removal Driver 4.5mm
• 00819034023141: Removal Driver 3.5mm
• 00819034023134: Removal Driver 2.5mm
• 00819034023127: Torx Driver 4.5mm
• 00819034023110: Torx Driver 3.5mm
• 00819034023103: Torx Driver 2.5mm
• 00819034023097: Cannulated Reamer 4.5mm
• 00819034023080: Cannulated Reamer 3.5mm
• 00819034023073: Cannulated Reamer 2.5mm
• 00819034023066: Calibrated Drill Cannulated 3.0mm
• 00819034023059: Calibrated Drill Cannulated 2.1mm
• 00819034023042: Calibrated Drill Cannulated 1.7mm
• 00819034029822: Fully Threaded CompressionScrew FT 3.5mm x 55mm
• 00819034029815: Fully Threaded CompressionScrew FT 3.5mm x 45mm
• 00819034029808: Fully Threaded CompressionScrew FT 3.5mm x 35mm
• 00819034029792: Fully Threaded CompressionScrew FT 2.5mm x 50mm
• 00819034029785: Fully Threaded CompressionScrew FT 2.5mm x 45mm
• 00819034029778: Fully Threaded CompressionScrew FT 2.5mm x 35mm
• 00840124506664: Tissue Protector 3.5mm
• 00840124506657: Tissue Protector 4.5mm
• 00840124506640: Tissue Protector 2.5mm