FuzeFix Mini TN-FX-9140

GUDID 00840124506633

Tissue Protector 4.0mm

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

• Primary Device ID: 00840124506633
• NIH Device Record Key: 4815e7ad-a3ed-4c6d-aa9f-2ab796c02250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FuzeFix Mini
• Version Model Number: TN-FX-9140
• Catalog Number: TN-FX-9140
• 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	00840124506633 [Primary]

FDA Product Code

• QAC: Screw Sleeve Bone Fixation Device

Sterilization

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

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

[00840124506633]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [FuzeFix Mini]

• 00819034023202: Screw Holding Forceps small
• 00819034023172: Depth Gauge HL
• 00819034023165: Depth Gauge HD
• 00819034022236: K-Wire Threaded 0.9 mm
• 00819034021628: Screw Extractor Rod 3.0mm and 4.0mm
• 00819034021604: Removal Driver Torx 4.0mm
• 00819034021598: Removal Driver Torx 3.0mm
• 00819034021581: Driver Torx 4.0mm
• 00819034021574: Driver Torx 3.0mm
• 00819034021567: Driver Torx 2.5mm
• 00819034021550: Driver Torx 2.0mm
• 00819034021543: K-Wire Threaded 1.1mm
• 00819034021536: K-Wire Standard 0.9mm
• 00819034021529: K-Wire Standard 1.1 mm
• 00819034021512: Proximal Reamer Headless 4.0mm
• 00819034021505: Proximal Reamer Headless 3.0mm
• 00819034021499: Proximal Reamer Headless 2.5mm
• 00819034021482: Proximal Reamer Headless 2.0mm
• 00819034021475: Proximal Reamer Cannulated 4.0 mm
• 00819034021468: Proximal Reamer Cannulated 3.0mm
• 00819034021451: Proximal Reamer Cannulated 2.5mm
• 00819034021444: Proximal Reamer Cannulated 2.0 mm
• 00819034021437: Calibrated Drill Cannulated 2.6 mm
• 00819034021420: Calibrated Drill Cannulated 2.2mm
• 00819034021413: Calibrated Drill Cannulated 1.9mm
• 00819034021406: Calibrated Drill Cannulated 1.7mm
• 00819034029846: Headless Screw HL 2.0mm x 37mm
• 00819034029839: Headless Screw HL 2.0mm x 32mm
• 00840124506909: Smooth Washer 4.0mm
• 00840124506893: Spiked Washer 3.0mnm
• 00840124507166: Cannulated Screw HD 4.0mm x 55mm
• 00840124506886: Cannulated Screw HD 4.00mm x 60mm
• 00840124506879: Cannulated Screw HD 4.0mm x 58mm
• 00840124506862: Cannulated Screw HD 4.0mm x 56mm
• 00840124506855: Cannulated Screw HD 4.0mm x 54mm
• 00840124506848: Cannulated Screw HD 4.0mm x 52mm
• 00840124506831: HL 4.0mm x 60mm
• 00840124506824: HL 4.0mm x 58mm
• 00840124506817: HL 4.0mm x 56mm
• 00840124506701: Tissue Protector Handle
• 00840124506633: Tissue Protector 4.0mm
• 00840124506626: Tissue Protector 3.0mm
• 00840124506619: Tissue Protector 2.5mm
• 00840124506602: Tissue Protector 2.0mm
• 00840124501812: Driver Handle Non-Ratcheting
• 00840124501805: Driver Handle Ratcheting
• 00819034029297: K-Wire Double Trocar 0.9mm
• 00819034029280: K-Wire Double Trocar 1.1mm
• 00840124507173: HL 4.0mm x 55mm
• 00840124506800: HL 4.0mm x 54mm