LEGION

Basic Information

• Brand Name: LEGION
• Primary DI: 00885556648308
• Version / Model: 71442265
• Catalog Number: 71442265
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-13
• Public Version: 9
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: b3cf2853-b30a-4760-94b5-0862b9d27807

Device Description

LEGION FASTPAK INSERT TRIAL SIZE 5-6 CRUCIATE RETAINING DEEP DISH

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66186	Knee tibia prosthesis trial, single-use	A copy of a final tibia prosthesis designed to be used during total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is a one-piece device made of polymer material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556648308	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143226	000