Attune

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: ATTUNE FDA UDI
Generic Name: Coated knee femur prosthesis FDA UDI
Device Name: ATTUNE FEMORAL POROCOAT POSTERIOR STABILIZED SIZE 9 RIGHT CEMENTLESS FDA UDI
Model / Reference: 1504-11-209 FDA UDI
Description: ATTUNE FEMORAL POROCOAT POSTERIOR STABILIZED SIZE 9 RIGHT CEMENTLESS FDA UDI

Identifiers

Catalog Number: 150411209 FDA UDI
Primary DI / UDI-DI: 10603295042082 FDA UDI
FDA Product Code: MBH FDA UDI
JWH FDA UDI
NJL FDA UDI
GMDN Term: Coated knee femur prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3565 FDA UDI
888.3560 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: Coated knee femur prosthesis

Attune by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
Persona® PPS® — Zimmer, Inc. · Class II
Genflex2 Total Knee System — GLOBUS MEDICAL, INC. · Class II
APEX PS Knee — OMNIlife science, 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: Depuy (ireland)

Sources (1)

FDA UDI 1b32b721-2c74-4405-8f4e-11c58f0c9ad4 35 fields · synced Jun 8, 2026