Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867033993
• Version / Model: AR-501-TBD9
• Catalog Number: AR-501-TBD9
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 6
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 726afef1-8d94-4c2f-95cd-d237206a5307

Device Description

IBALANCE UKA TIBIAL BEARING, SIZE 4, 9MM

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: MR Conditional
• 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
KRR	PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34195	Unicondylar knee prosthesis	A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867033993	GS1
Secondary	M150AR501TBD92	HIBCC

Customer Contacts

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