U2™ Knee

Basic Information

• Brand Name: U2™ Knee
• Primary DI: 04719872176848
• Version / Model: 9403-5333
• Catalog Number: 9403-5333
• Company Name: UNITED ORTHOPEDIC CORP.
• Labeler DUNS: 656700556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-29
• Public Version: 3
• Public Version Date: 2018-05-31
• Public Version Status: Update
• Public Device Record Key: 53478c3c-b070-425f-9dc9-0a5c0e05440a

Device Description

Offset bushing wrench

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
HXC	Wrench	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47870	Orthopaedic fixation implant alignment tool	A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719872176848	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]