← Back to catalogue
Augments
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1523-09-102Model ATTUNE Revision Augments
Identity
- Trade Name
- ATTUNE FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- Augments EUDAMEDATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 10MM LM/RL CEMENTED SIZE 9/10 FDA UDI
- Model / Reference
- ATTUNE Revision Augments EUDAMED1523-09-102 EUDAMEDFDA UDI
- Description
- ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT 10MM LM/RL CEMENTED SIZE 9/10 FDA UDI
Identifiers
- Catalog Number
- 152309102 FDA UDI
- Primary DI / UDI-DI
- 10603295057703 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0044692 EUDAMED
- FDA Product Code
- MBH FDA UDIJWH FDA UDINJL FDA UDI
- EMDN Code
- P09098001 KNEE PROSTHESES AUGMENTS EUDAMED
- GMDN Term
- Knee arthroplasty wedge FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Augments by DePuy Ireland UC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a0044692 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED ad9777b7-c724-4b98-86d7-413b3b76cfa0 61 fields · synced Jun 18, 2026
- FDA UDI 06e2bac8-6e9f-4a3e-8a83-263ac5dd54cb 35 fields · synced May 30, 2026