FuzeFix Large

Basic Information

• Brand Name: FuzeFix Large
• Primary DI: 00819034029686
• Version / Model: TN-FX-7094
• Catalog Number: TN-FX-7094
• Company Name: FUSION ORTHOPEDICS, LLC
• Labeler DUNS: 080307067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-19
• Public Version: 1
• Public Version Date: 2021-04-27
• Public Version Status: New
• Public Device Record Key: 93133cce-83b0-473e-b3b6-85fd00684bfb

Device Description

FX Parallel Wire Guide HL 5.5mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37825	Antimicrobial orthopaedic bone pin/wire sleeve	A small diameter plastic tube placed over the orthopaedic pins or wires used during the external fixation of bones, to inhibit bacterial colonization on or around the pins or wires during healing. It is typically made of polyurethane and is coated on the inner and outer surfaces with an antimicrobial agent. It is available in various diameters and/or designs to match orthopaedic pin/wire diameters. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819034029686	GS1

Premarket Submissions

Submission Number	Supplement Number
K170038	000