Arthrex®

FDA UDI

Class I (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Patella prosthesis trial FDA UDI
Device Name: IBAL TKA, DOME PAT TRL,SZ 32,8MM THK FDA UDI
Model / Reference: AR-603-328 FDA UDI
Description: IBAL TKA, DOME PAT TRL,SZ 32,8MM THK FDA UDI

Identifiers

Catalog Number: AR-603-328 FDA UDI
Primary DI / UDI-DI: 00888867318380 FDA UDI
FDA Product Code: LXH FDA UDI
HWT FDA UDI
GMDN Term: Patella prosthesis trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Patella prosthesis trial

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

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EXULT Knee Replacement System — Corentec Co., Ltd · Class II
Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
Sombrero Patella Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
Biomet® Series A™ — Biomet Orthopedics, Inc. · Class II
JOURNEY — Smith & Nephew, Inc. · Class II
Gender Solutions® Natural-Knee® — Zimmer, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Arthrex, Inc.

Sources (1)

FDA UDI 97925f73-2cd1-46f4-9f1c-7829f5e747b3 35 fields · synced May 30, 2026