Identity
- Trade Name
- ATTUNE FDA UDI
- Generic Name
- Coated knee tibia prosthesis FDA UDI
- Device Name
- Attune Knee System TIBIAL BASE POROCOAT ROTATING PLATFORM SIZE 8 CEMENTLESS FDA UDI
- Model / Reference
- 1506-11-008 FDA UDI
- Description
- Attune Knee System TIBIAL BASE POROCOAT ROTATING PLATFORM SIZE 8 CEMENTLESS FDA UDI
Identifiers
- Catalog Number
- 150611008 FDA UDI
- Primary DI / UDI-DI
- 10603295416302 FDA UDI
- FDA Product Code
- NJL FDA UDI
- GMDN Term
- Coated knee tibia prosthesis FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Coated knee tibia prosthesis
Attune by Depuy (ireland) — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee tibia prosthesis.
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- Consensus Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Natural-Knee® — Zimmer, Inc. · Class II
- Balanced Knee System — ORTHO DEVELOPMENT CORP. · Class II
- OMNI Knee — OMNIlife science, Inc. · Class II
- Columbus® CR/PS — AESCULAP, INC. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- JOURNEY — Smith & Nephew, 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 III | Pending data |
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Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (1)
- FDA UDI 33b7fbc5-cdab-4c28-aa83-79d423881e3c 35 fields · synced May 31, 2026