Attune

FDA UDI

Class III (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: ATTUNE FDA UDI
Generic Name: Sleeve femoral/tibial extension, coated FDA UDI
Device Name: ATTUNE KNEE SYSTEM REVISION CONCENTRIC CONE X-LARGE FDA UDI
Model / Reference: 1514-04-160 FDA UDI
Description: ATTUNE KNEE SYSTEM REVISION CONCENTRIC CONE X-LARGE FDA UDI

Identifiers

Catalog Number: 151404160 FDA UDI
Primary DI / UDI-DI: 10603295522621 FDA UDI
FDA Product Code: NJL FDA UDI
JWH FDA UDI
MBH FDA UDI
GMDN Term: Sleeve femoral/tibial extension, coated FDA UDI

Classification

Device Class: Class III FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 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: Sleeve femoral/tibial extension, coated

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

Similar devices

Also classified as Sleeve femoral/tibial extension, coated.

S-ROM ZTT — DEPUY ORTHOPAEDICS, INC. · Class III
Coated Revision Stem — Signal Medical Corp. · Class II
AMF TT CONES — Limacorporate · Class II
AMF TT CONES — Limacorporate · Class II
AMF TT CONES — Limacorporate · Class II
Optetrak Logic — Exactech, Inc. · Class II
Balanced Knee Revision System — ORTHO DEVELOPMENT CORP. · Class II
Coated Revision Stem — Signal Medical Corp. · 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 III	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI d8f53df7-44d1-4213-b42d-4dff23721767 35 fields · synced Jun 6, 2026