Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Uncoated knee tibia/insert prosthesis FDA UDI
Device Name: IBAL TKA TIB BEA-RING IMP CR,SZ 10,14MM FDA UDI
Model / Reference: AR-513-RL14 FDA UDI
Description: IBAL TKA TIB BEA-RING IMP CR,SZ 10,14MM FDA UDI

Identifiers

Catalog Number: AR-513-RL14 FDA UDI
Primary DI / UDI-DI: 00888867108813 FDA UDI
FDA Product Code: MBH FDA UDI
HSX FDA UDI
KRR FDA UDI
GMDN Term: Uncoated knee tibia/insert prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3565 FDA UDI
888.3520 FDA UDI
888.3540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Uncoated knee tibia/insert prosthesis

Arthrex® by Arthrex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated knee tibia/insert prosthesis.

Vanguard Complete Knee System — Biomet Orthopedics, Inc. · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II
LOSPA Modular Knee System — Corentec Co., Ltd · Class II
LOSPA Modular Knee System — Corentec Co., Ltd · Class II
Vanguard Knee System — Biomet Orthopedics, Inc. · Class II
Vanguard® Complete Knee System — Biomet Orthopedics, Inc. · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Arthrex, Inc.

Sources (1)

FDA UDI d9f015df-418d-4e1a-a8db-db2077f85a4f 35 fields · synced May 31, 2026