AR Specialty Femoral

FDA UDI

Class II (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name: AR Specialty Femoral FDA UDI
Generic Name: Knee femur prosthesis trial, reusable FDA UDI
Device Name: Femoral Trial - Size 6, 6N, Left FDA UDI
Model / Reference: 8829P00057 FDA UDI
Description: Femoral Trial - Size 6, 6N, Left FDA UDI

Identifiers

Catalog Number: 8829P00057 FDA UDI
Primary DI / UDI-DI: 00843575112736 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 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

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

MRI Safety

MR Conditional FDA UDI

Category: Knee femur prosthesis trial, reusable

AR Specialty Femoral by b-ONE Ortho Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Natural-Knee® — Zimmer, Inc. · Class II
NexGen® — Zimmer, Inc. · Class II
LOSPA Knee System — Corentec Co., Ltd · Class II
Persona® — Zimmer, Inc. · 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: b-ONE Ortho Corp.

Sources (1)

FDA UDI b16d9fab-2df3-4b48-ad74-fe4ab596b9c6 34 fields · synced May 30, 2026