FuzeFix Max FT TN-FT-9145

GUDID 00840124506657

Tissue Protector 4.5mm

FUSION ORTHOPEDICS, LLC

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00840124506657
• NIH Device Record Key: baaeaf31-c994-4ef9-b8da-0cca88f94120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Max FT
• Version Model Number: TN-FT-9145
• Catalog Number: TN-FT-9145
• 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	00840124506657 [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

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

Moist Heat or Steam Sterilization

[00840124506657]

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