ZUK

Basic Information

• Brand Name: ZUK
• Primary DI: 00885556620366
• Version / Model: 00584203114
• Catalog Number: 00584203114
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-02-15
• Public Version: 5
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 028c37fe-f0a7-4a07-91ee-bf22405fc71d

Device Description

ZUK All-Poly Tibia Size 1 14mm Left Medial/Right Lateral

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSX	PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48069	Uncoated unicondylar knee tibia prosthesis, polyethylene	A sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of polyethylene (PE) and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component, and its implantation is intended to be performed with bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556620366	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033363	000